Effect of Linaclotide on Colonic Motility Assessed With Intraluminal Colonic High-Resolution Manometry in Healthy Subjects. An Acute, Open Label, Randomized, Crossover, Reader-Blinded Study.

Lambiase C, Pagliaro G, Cocca S, Deloose E, Demedts I, Morganti R, Tack J, Corsetti M

Neurogastroenterology and motility18 Dec 2025

PMID41413756DOI10.1111/nmo.70222PepBankPUB-41413756

Publisher page PubMedAsk about this study

Summary

BackgroundPolyethilenglicole (PEG), bisacodyl, prucalopride, and linaclotide were demonstrated to be superior to placebo for the treatment of chronic constipation. In a recent study, we reported the actions of PEG, bisacodyl, and prucalopride on colonic motor patterns. The aim of the present study was to evaluate the effect of linaclotide as compared to placebo on colonic motility assessed with high-resolution manometry (HRM).MethodsIn 10 volunteers (30.3 ± 10.6 years), two colonic HRM studies (40 solid-state sensors, 2.5 cm spaced) were performed at least 10 days apart. After 90 min of basal recording, linaclotide 290 μg or placebo was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal. Colonic motility index (MI) of the right, left colon, and rectum, expressed as a ratio of the baseline value, was compared between treatments by means of a mixed model analysis. The number of high-amplitude propagated sequences, of long-distance propagating sequences, and of pan-colonic pressurizations was compared between treatments.ResultsLinaclotide induced more long-distance propagating sequences than placebo (34.9 ± 41.2 vs. 3.0 ± 5.2, p = 0.026), especially during the meal and post-meal phases of the recording. The total number of pancolonic pressurizations did not differ between treatments. However, a significant increase in the mean number of pre-prandial pancolonic pressurizations was observed following linaclotide administration (p = 0.043). No treatment effect was found on the change in colonic MI from the baseline in any region of the colon.ConclusionsIn healthy controls, acute administration of linaclotide increases the total number of long-distance propagating sequences and the pre-prandial pancolonic pressurizations.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In healthy volunteers, linaclotide induced more long-distance propagating sequences than placebo, especially during meal and post-meal recordings.
In plain wordsIn healthy volunteers, linaclotide produced more long-distance colon contractions than placebo.
Peptide
Linaclotide
Outcome
IncreaseLong-distance propagating sequences
Study
n = 10
Comparator
Placebo
Outcome group
Colonic Motility · Gastrointestinal
Studied dose
290 μg · oralAs given in this study (human).
Measurements
Long-distance propagating sequences
34.9 sequences
linaclotide mean; SD 41.2
Long-distance propagating sequences
3 sequences
placebo mean; SD 5.2
P value
0.026 NA
between treatments
Source sentences
Summary
Linaclotide induced more long-distance propagating sequences than placebo (34.9 ± 41.2 vs. 3.0 ± 5.2, p = 0.026), especially during the meal and post-meal phases of the recording.
2 context sentences(design, population, supporting numbers)
Summary · context
In 10 volunteers (30.3 ± 10.6 years), two colonic HRM studies (40 solid-state sensors, 2.5 cm spaced) were performed at least 10 days apart.
Summary · context
After 90 min of basal recording, linaclotide 290 μg or placebo was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal.
Show in the study text Report a problemFND-4141375601
02HumanRandomized controlled trialEfficacy outcome
In healthy volunteers, total pancolonic pressurizations did not differ between linaclotide and placebo.
In plain wordsIn healthy volunteers, total pancolonic pressurizations did not differ between linaclotide and placebo.
Peptide
Linaclotide
Outcome
No significant changeTotal pancolonic pressurizations
Study
n = 10
Comparator
Placebo
Outcome group
Colonic Motility · Gastrointestinal
Studied dose
290 μg · oralAs given in this study (human).
Source sentences
Summary
The total number of pancolonic pressurizations did not differ between treatments.
2 context sentences(design, population, supporting numbers)
Summary · context
In 10 volunteers (30.3 ± 10.6 years), two colonic HRM studies (40 solid-state sensors, 2.5 cm spaced) were performed at least 10 days apart.
Summary · context
After 90 min of basal recording, linaclotide 290 μg or placebo was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal.
Show in the study text Report a problemFND-4141375602
03HumanRandomized controlled trialEfficacy outcome
In healthy volunteers, mean pre-prandial pancolonic pressurizations were significantly higher after linaclotide than after placebo (p = 0.043).
In plain wordsIn healthy volunteers, pre-meal pancolonic pressurizations were higher after linaclotide than after placebo.
Peptide
Linaclotide
Outcome
IncreasePre-prandial pancolonic pressurizations
Study
n = 10
Comparator
Placebo
Outcome group
Colonic Motility · Gastrointestinal
Studied dose
290 μg · oralAs given in this study (human).
Source sentences
Summary
However, a significant increase in the mean number of pre-prandial pancolonic pressurizations was observed following linaclotide administration (p = 0.043).
2 context sentences(design, population, supporting numbers)
Summary · context
In 10 volunteers (30.3 ± 10.6 years), two colonic HRM studies (40 solid-state sensors, 2.5 cm spaced) were performed at least 10 days apart.
Summary · context
After 90 min of basal recording, linaclotide 290 μg or placebo was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal.
Show in the study text Report a problemFND-4141375603
04HumanRandomized controlled trialEfficacy outcome
In healthy volunteers, linaclotide had no treatment effect versus placebo on motility index change from baseline in any colonic region.
In plain wordsIn healthy volunteers, colonic motility index changes did not differ between linaclotide and placebo in any region.
Peptide
Linaclotide
Outcome
No significant changeRegional colonic motility index changes
Study
n = 10
Comparator
Placebo
Outcome group
Colonic Motility · Gastrointestinal
Studied dose
290 μg · oralAs given in this study (human).
Source sentences
Summary
No treatment effect was found on the change in colonic MI from the baseline in any region of the colon.
3 context sentences(design, population, supporting numbers)
Summary · context
Colonic motility index (MI) of the right, left colon, and rectum, expressed as a ratio of the baseline value, was compared between treatments by means of a mixed model analysis.
Summary · context
In 10 volunteers (30.3 ± 10.6 years), two colonic HRM studies (40 solid-state sensors, 2.5 cm spaced) were performed at least 10 days apart.
Summary · context
After 90 min of basal recording, linaclotide 290 μg or placebo was administered orally in double-blind, randomized, cross-over fashion, and the recording continued for 180 min before and after a standardized meal.
Show in the study text Report a problemFND-4141375604

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

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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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