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Study · Randomized controlled trial · n = 39 · 2020

15 results

Randomised clinical trial: linaclotide vs placebo-a study of bi-directional gut and brain axis.

Rao SSC, Xiang X, Yan Y, Rattanakovit K, Patcharatrakul T, Parr R, Ayyala D, Sharma A

Alimentary pharmacology & therapeutics13 May 2020Cited by 23 (Europe PMC)

PMID32406112 (opens in a new tab)PMCIDPMC7384154 (opens in a new tab)DOI10.1111/apt.15772 (opens in a new tab)PepBankPUB-32406112
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study15

15 results from studies that gave the peptide. 15 results from people.

  1. 01HumanRandomized controlled trialMechanism

    In IBS-C patients, rectal cortical P1 latency did not differ significantly between linaclotide and placebo.

    In plain wordsIn IBS-C patients, rectal cortical P1 latency did not differ significantly between linaclotide and placebo.

    Peptide
    Linaclotide
    Outcome
    No significant changeRectal cortical P1 latency versus placebo
    Study

    n = 39

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Measurements

    P1 latency change from baseline
    19 milliseconds
    linaclotide
    P1 latency change from baseline
    3 milliseconds
    placebo

    Source sentences

    Summary
    Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P < 0.005; N1:Δ 20 ± 7, P < 0.02) but not with placebo (P1:Δ 3 ± 5; N1:Δ 4.7 ± 5,P = 0.3) or between groups.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  2. 02HumanRandomized controlled trialMechanism

    In IBS-C patients, rectal cortical N1 latency did not differ significantly between linaclotide and placebo.

    In plain wordsIn IBS-C patients, rectal cortical N1 latency did not differ significantly between linaclotide and placebo.

    Peptide
    Linaclotide
    Outcome
    No significant changeRectal cortical N1 latency versus placebo
    Study

    n = 39

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Measurements

    N1 latency change from baseline
    20 milliseconds
    linaclotide
    N1 latency change from baseline
    4.7 milliseconds
    placebo

    Source sentences

    Summary
    Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P < 0.005; N1:Δ 20 ± 7, P < 0.02) but not with placebo (P1:Δ 3 ± 5; N1:Δ 4.7 ± 5,P = 0.3) or between groups.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In IBS-C patients, maximum tolerable rectal volume increased more with linaclotide than placebo (29 ± 10 versus 4 ± 20 cc).

    In plain wordsIn IBS-C patients, linaclotide increased tolerable rectal volume more than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseMaximum tolerable rectal volume versus placebo
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Pain · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Measurements

    Change in maximum tolerable rectal volume
    29 cc
    linaclotide
    Change in maximum tolerable rectal volume
    4 cc
    placebo

    Source sentences

    Summary
    The maximum tolerable rectal volume (cc) increased significantly with linaclotide compared to baseline (P < 0.001) and placebo (Δ 29 ± 10 vs 4 ± 20, (P < 0.03).
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In IBS-C patients, abdominal pain did not differ significantly between linaclotide and placebo.

    In plain wordsIn IBS-C patients, abdominal pain did not differ significantly between linaclotide and placebo.

    Peptide
    Linaclotide
    Outcome
    No significant changeAbdominal pain versus placebo
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Pain · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    Abdominal pain decreased (P < 0.001) with linaclotide but not between groups.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In IBS-C patients, linaclotide increased complete spontaneous bowel movement frequency versus placebo (P < 0.001).

    In plain wordsIn IBS-C patients, linaclotide increased complete spontaneous bowel movement frequency compared with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseComplete spontaneous bowel movement frequency
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In IBS-C patients, linaclotide improved IBS-QOL scores versus placebo (P = 0.01).

    In plain wordsIn IBS-C patients, linaclotide improved quality of life compared with placebo.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedIBS quality of life
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Quality of life · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In IBS-C patients, overall response was 54% with linaclotide versus 23% with placebo, without a significant difference (P = 0.13).

    In plain wordsIn IBS-C patients, response was numerically higher with linaclotide than placebo, but the difference was not significant.

    Peptide
    Linaclotide
    Outcome
    IncreaseOverall response
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Measurements

    Overall responders
    54%
    linaclotide
    Overall responders
    23%
    placebo

    Source sentences

    Summary
    There was no difference in overall responders between linaclotide and placebo (54% vs 23%, P = 0.13).
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  8. 08HumanNon-randomized trialMechanism

    In IBS-C patients, linaclotide prolonged rectal cortical P1 latency by 19 ± 6 milliseconds versus baseline.

    In plain wordsIn IBS-C patients, linaclotide prolonged rectal cortical P1 latency compared with baseline.

    Peptide
    Linaclotide
    Outcome
    IncreaseRectal cortical P1 latency
    Study

    n = 26

    Comparator
    Baseline
    Analysis
    Primary
    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Measurements

    P1 latency change
    19 milliseconds
    versus baseline

    Source sentences

    Summary
    Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P < 0.005; N1:Δ 20 ± 7, P < 0.02) but not with placebo (P1:Δ 3 ± 5; N1:Δ 4.7 ± 5,P = 0.3) or between groups.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  9. 09HumanNon-randomized trialMechanism

    In IBS-C patients, linaclotide prolonged rectal cortical N1 latency by 20 ± 7 milliseconds versus baseline.

    In plain wordsIn IBS-C patients, linaclotide prolonged rectal cortical N1 latency compared with baseline.

    Peptide
    Linaclotide
    Outcome
    IncreaseRectal cortical N1 latency
    Study

    n = 26

    Comparator
    Baseline
    Analysis
    Primary
    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Measurements

    N1 latency change
    20 milliseconds
    versus baseline

    Source sentences

    Summary
    Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P < 0.005; N1:Δ 20 ± 7, P < 0.02) but not with placebo (P1:Δ 3 ± 5; N1:Δ 4.7 ± 5,P = 0.3) or between groups.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  10. 10HumanNon-randomized trialEfficacy outcome

    In IBS-C patients, linaclotide increased maximum tolerable rectal volume versus baseline (P < 0.001).

    In plain wordsIn IBS-C patients, linaclotide increased tolerable rectal volume compared with baseline.

    Peptide
    Linaclotide
    Outcome
    IncreaseMaximum tolerable rectal volume versus baseline
    Study

    n = 26

    Comparator
    Baseline
    Outcome group
    Pain · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Measurements

    Change in maximum tolerable rectal volume
    29 cc
    linaclotide

    Source sentences

    Summary
    The maximum tolerable rectal volume (cc) increased significantly with linaclotide compared to baseline (P < 0.001) and placebo (Δ 29 ± 10 vs 4 ± 20, (P < 0.03).
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  11. 11HumanNon-randomized trialEfficacy outcome

    In IBS-C patients, abdominal pain decreased from baseline with linaclotide (P < 0.001).

    In plain wordsIn IBS-C patients, abdominal pain decreased with linaclotide compared with baseline.

    Peptide
    Linaclotide
    Outcome
    DecreaseAbdominal pain versus baseline
    Study

    n = 26

    Comparator
    Baseline
    Outcome group
    Pain · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    Abdominal pain decreased (P < 0.001) with linaclotide but not between groups.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  12. 12HumanNon-randomized trialEfficacy outcome

    In IBS-C patients, linaclotide increased complete spontaneous bowel movement frequency compared with baseline (P < 0.001).

    In plain wordsIn IBS-C patients, linaclotide increased complete spontaneous bowel movement frequency compared with baseline.

    Peptide
    Linaclotide
    Outcome
    IncreaseComplete spontaneous bowel movement frequency versus baseline
    Study

    n = 26

    Comparator
    Baseline
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  13. 13HumanNon-randomized trialEfficacy outcome

    In IBS-C patients, linaclotide improved IBS-QOL scores compared with baseline (P = 0.01).

    In plain wordsIn IBS-C patients, linaclotide improved quality of life compared with baseline.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedIBS quality of life versus baseline
    Study

    n = 26

    Comparator
    Baseline
    Outcome group
    Quality of life · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    Complete spontaneous bowel movement frequency increased (P < 0.001), and IBS-QOL scores improved (P = 0.01) with linaclotide compared to baseline and placebo.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  14. 14HumanNon-randomized trialMechanism

    In IBS-C patients receiving linaclotide, efferent cortico-anorectal latency remained unchanged.

    In plain wordsIn IBS-C patients receiving linaclotide, efferent cortico-anorectal latency remained unchanged.

    Peptide
    Linaclotide
    Outcome
    No significant changeEfferent cortico-anorectal latency
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    The efferent cortico-anorectal and spino-anorectal latencies were unchanged.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.
  15. 15HumanNon-randomized trialMechanism

    In IBS-C patients receiving linaclotide, spino-anorectal latency remained unchanged.

    In plain wordsIn IBS-C patients receiving linaclotide, spino-anorectal latency remained unchanged.

    Peptide
    Linaclotide
    Outcome
    No significant changeSpino-anorectal latency
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    290 µg · 10 weeksAs given in this study (human).

    Source sentences

    Summary
    The efferent cortico-anorectal and spino-anorectal latencies were unchanged.
    1 context sentence
    Summary · context
    Patients with IBS-C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi-directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal-anorectal magnetic stimulations.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableNCT02078323

Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients

Augusta Universityn = 39Feb 2014 to 20 Jul 2018

Irritable Bowel Syndrome With Constipation (IBS-C)

Trial pageClinicalTrials.govUpdated 23 Jul 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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