Pilot study on the effect of linaclotide in patients with chronic constipation.

Johnston JM, Kurtz CB, Drossman DA, Lembo AJ, Jeglinski BI, MacDougall JE, Antonelli SM, Currie MG

The American journal of gastroenterology1 Jan 2009Cited by 83 (Europe PMC)

PMID19098860DOI10.1038/ajg.2008.59PepBankPUB-19098860

Publisher page PubMedAsk about this study

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with chronic constipation, linaclotide 100 microg/day significantly increased spontaneous bowel movement frequency versus placebo.
In plain wordsIn patients with chronic constipation, linaclotide increased spontaneous bowel movement frequency compared with placebo.
Peptide
Linaclotide
Outcome
IncreaseSpontaneous bowel movement frequency
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Bowel Function · Gastrointestinal
Studied dose
100 microg/day · oral · 2 weeksAs given in this study (human).
Source sentences
Summary
Compared to placebo, linaclotide 100 microg/day significantly increased spontaneous bowel movement frequency, and linaclotide 1,000 microg/day significantly improved stool consistency (P<0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of oral linaclotide in 42 patients with chronic constipation.
Summary · context
Patients were randomized to linaclotide (100, 300, or 1,000 microg) or placebo once daily for 2 weeks.
Report a problemFND-1909886005
02HumanRandomized controlled trialEfficacy outcome
In patients with chronic constipation, linaclotide 1,000 microg/day significantly improved stool consistency versus placebo (P<0.05).
In plain wordsIn patients with chronic constipation, linaclotide improved stool consistency compared with placebo.
Peptide
Linaclotide
Outcome
IncreaseStool consistency
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Bowel Function · Gastrointestinal
Studied dose
1,000 microg/day · oral · 2 weeksAs given in this study (human).
Source sentences
Summary
Compared to placebo, linaclotide 100 microg/day significantly increased spontaneous bowel movement frequency, and linaclotide 1,000 microg/day significantly improved stool consistency (P<0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of oral linaclotide in 42 patients with chronic constipation.
Summary · context
Patients were randomized to linaclotide (100, 300, or 1,000 microg) or placebo once daily for 2 weeks.
Report a problemFND-1909886006
03HumanNon-randomized trialEfficacy outcome
In patients with chronic constipation, weekly complete spontaneous bowel movement frequency rose from baseline by 2.2-3.2 across linaclotide doses (dose-dependent) and by 1.3 in the placebo group.
In plain wordsIn patients with chronic constipation, weekly complete bowel movements rose from baseline by 2.2 to 3.2 with linaclotide and by 1.3 with placebo.
Peptide
Linaclotide
Outcome
IncreaseComplete spontaneous bowel movement frequency
Study
n = 42
Comparator
Pretreatment baseline values; placebo change also reported
Analysis
Exploratory
Outcome group
Bowel Function · Gastrointestinal
Studied dose
100, 300, or 1,000 microg once daily · oral · 2 weeksAs given in this study (human).
Measurements
Increase in weekly complete spontaneous bowel movement frequency from baseline
2.2 to 3.2 CSBMs per week
linaclotide 100, 300, or 1,000 microg once daily
Increase in weekly complete spontaneous bowel movement frequency from baseline
1.3 CSBMs per week
placebo
Source sentences
Summary
Linaclotide treatment produced dose-dependent increases from the pretreatment baseline values in weekly complete spontaneous bowel movement frequency (range: 2.2-3.2)
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of oral linaclotide in 42 patients with chronic constipation.
Summary · context
Patients were randomized to linaclotide (100, 300, or 1,000 microg) or placebo once daily for 2 weeks.
Report a problemFND-1909886001
04HumanNon-randomized trialEfficacy outcome
In patients with chronic constipation, stool consistency scores rose from baseline by 1.1-2.6 points on a 7-point scale across linaclotide doses and by 0.4 in the placebo group.
In plain wordsIn patients with chronic constipation, stool consistency scores rose from baseline by 1.1 to 2.6 with linaclotide and by 0.4 with placebo.
Peptide
Linaclotide
Outcome
IncreaseStool consistency score change
Study
n = 42
Comparator
Pretreatment baseline values; placebo change also reported
Analysis
Exploratory
Outcome group
Bowel Function · Gastrointestinal
Studied dose
100, 300, or 1,000 microg once daily · oral · 2 weeksAs given in this study (human).
Measurements
Increase in stool consistency score from baseline (7-point scale)
1.1 to 2.6 points
linaclotide 100, 300, or 1,000 microg once daily
Increase in stool consistency score from baseline (7-point scale)
0.4 points
placebo
Source sentences
Summary
stool consistency scores (range: 1.1-2.6, 7-point scale)
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of oral linaclotide in 42 patients with chronic constipation.
Summary · context
Patients were randomized to linaclotide (100, 300, or 1,000 microg) or placebo once daily for 2 weeks.
Report a problemFND-1909886002
05HumanNon-randomized trialEfficacy outcome
In patients with chronic constipation, straining scores rose from baseline by 0.4-1.5 points on a 7-point scale across linaclotide doses and by 0.4 in the placebo group.
In plain wordsIn patients with chronic constipation, straining scores rose from baseline by 0.4 to 1.5 with linaclotide and by 0.4 with placebo.
Peptide
Linaclotide
Outcome
IncreaseStraining score change
Study
n = 42
Comparator
Pretreatment baseline values; placebo change also reported
Analysis
Exploratory
Outcome group
Bowel Function · Gastrointestinal
Studied dose
100, 300, or 1,000 microg once daily · oral · 2 weeksAs given in this study (human).
Measurements
Increase in straining score from baseline (7-point scale)
0.4 to 1.5 points
linaclotide 100, 300, or 1,000 microg once daily
Increase in straining score from baseline (7-point scale)
0.4 points
placebo
Source sentences
Summary
straining scores (range: 0.4-1.5, 7-point scale)
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of oral linaclotide in 42 patients with chronic constipation.
Summary · context
Patients were randomized to linaclotide (100, 300, or 1,000 microg) or placebo once daily for 2 weeks.
Report a problemFND-1909886003
06HumanNon-randomized trialEfficacy outcome
In patients with chronic constipation, linaclotide treatment improved abdominal discomfort, constipation severity and overall relief.
In plain wordsIn patients with chronic constipation, abdominal discomfort, constipation severity and overall relief improved during linaclotide treatment.
Peptide
Linaclotide
Outcome
Direction not reportedAbdominal discomfort, constipation severity and overall relief
Study
n: not reported in source
Analysis
Exploratory
Outcome group
Bowel Function · Gastrointestinal
Studied dose
100, 300, or 1,000 microg once daily · oral · 2 weeksAs given in this study (human).
Source sentences
Summary
Clinical improvements were also demonstrated in abdominal discomfort, severity of constipation, and overall relief.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of oral linaclotide in 42 patients with chronic constipation.
Summary · context
Patients were randomized to linaclotide (100, 300, or 1,000 microg) or placebo once daily for 2 weeks.
Report a problemFND-1909886004
07HumanNon-randomized trialSafety outcome
In patients with chronic constipation receiving linaclotide, adverse events were primarily gastrointestinal, with diarrhea most common.
In plain wordsIn patients with chronic constipation receiving linaclotide, diarrhea was the most common adverse event.
Peptide
Linaclotide
Outcome
Direction not reportedGastrointestinal adverse events and diarrhea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
100, 300, or 1,000 microg once daily · oral · 2 weeksAs given in this study (human).
Source sentences
Summary
Adverse events were primarily gastrointestinal, with diarrhea being the most common.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled pilot study evaluated the safety, tolerability, and exploratory efficacy of oral linaclotide in 42 patients with chronic constipation.
Summary · context
Patients were randomized to linaclotide (100, 300, or 1,000 microg) or placebo once daily for 2 weeks.
Report a problemFND-1909886007

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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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