CompletedNCT01190020Updated Jan 15, 2019Results posted

Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.

A Phase 1 interventional study of Lubiprostone and Lubiprostone Control in Chronic Constipation, Methanogenesis, sponsored by Augusta University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Augusta University · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 41
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Lubiprostone, a chloride channel activator, has been shown to improve symptoms of chronic constipation, largely by enhancing chloride-rich intestinal fluid secretion. Whether Lubiprostone has effects on colonic methanogenesis is not known. The investigators hypothesize that the effects of Lubiprostone may in part be due to its effects on altering colonic flora, particularly methanogenic flora.

By altering the colonic stasis of stool and through more efficient clearance of digestive residue, the investigators anticipate that Lubiprostone may either inhibit or promote better excretion of methanogenic flora, and thereby decrease the gut load of methane producing bacteria. In turn, this may lead to enhanced colonic smooth muscle contraction and an increased rate of spontaneous bowel movements and reduction of constipation symptoms.

The aim is to investigate the effects of Lubiprostone on intestinal methane production and bowel symptoms in patients with chronic constipation, by performing a randomized, double blind, placebo controlled study.

Conditions studied

Chronic Constipation, Methanogenesis

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Constipation 1,018

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 41 is below the median of 80 across 850 interventional studies indexed under Constipation.

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Lead sponsor

Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Constipation as defined by Rome III criteria13. Patients must have symptoms > 3 days/month for the past three months and report at least two of the following symptoms ≥ 25% of the time: straining, lumpy or hard stool, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, use of manual maneuvers, \< 3 bowel movements/week. Also,they should have insufficient criteria for IBS, and only rarely loose stools without the use of laxatives.
≥ 3 ppm methane value at baseline1, 2(before sugar load).

Exclusion criteria

Exclusion Criteria:

Patients taking drugs that are known to be constipating will be excluded or asked to discontinue medications for at least 2 weeks and reassessed. For example, we will recommend that patients taking calcium channel antagonists contact their respective primary care physicians to explore alternative medications for hypertension such as beta blockers or ACE-inhibitors. If the calcium channel antagonists are able to be discontinued, patients will be re-screened at least two weeks after the medications are discontinued. If patients no longer meet inclusion criteria, they will be excluded from the study. Patients who remain constipated will be eligible for enrollment.
Patients with co-morbid illnesses such as severe cardiovascular disease, chronic renal failure, or those with previous gastrointestinal surgery except cholecystectomy and appendectomy
Patients with neurologic diseases such as multiple sclerosis, strokes, spinal cord injuries, and those who have problems with cognizance, i.e. a mini-mental score of \<15 and/or are legally blind will be excluded.
Women who are pregnant or are likely to conceive during the course of the study will be excluded. Urinary pregnancy tests will be performed on all women of child-bearing potential prior to enrollment and before any x-ray of the abdomen.
Patients with Hirschsprung' s disease, or active local anorectal problems such as anal fissures, bleeding hemorrhoids, Crohn's, colitis, or colon cancer.
Patients with alternating constipation and diarrhea and those who fulfill the Rome-III criteria for irritable bowel syndrome.
Recent antibiotic use (last 6 weeks).
Patients using laxatives, PEG or Tegaserod and unwilling to discontinue these medications at least 2 weeks prior to the study.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 41 participants (actual)

Study arms

Active comparator
Lubiprostone
24mcg BID for 4 weeks, oral medication
Drug: Lubiprostone
Placebo comparator
Placebo
24mcg BID for 4 weeks (placebo), oral medication
Drug: Lubiprostone Control

Interventions

DrugLubiprostone
Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed.
DrugLubiprostone Control
Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed.

What researchers measure

Primary outcomes

Change in Methane Production
Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study.
Time frame: Baseline and 1 month

Secondary outcomes

Stool Frequency (Complete Spontaneous Bowel Movements)
change in mean stool frequency (delta) between baseline week and final week of study
Time frame: Baseline and 1 month
Percentage Change in the Colonic Transit Time
Percentage change of colonic transit time between the baseline colonic transit study and the colonic transit study at the end of study
Time frame: Baseline and 1 month
Peak Methane Value
The peak methane value measured during the baseline breath study will be compared with the peak methane obtained at the end of study breath test
Time frame: Baseline and 1 month

Results

Posted Jan 15, 2019

Participant flow

Participant flow — Overall Study
Milestone	Lubiprostone	Placebo
Started	29	12
Completed	22	12
Not completed	7	0
Withdrew: Adverse event	2	0
Withdrew: Lost to follow-up	2	0
Withdrew: Withdrawal by subject	3	0

Outcome measures

PrimaryChange in Methane Production

Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study.

Time frame:: Baseline and 1 month
Reported as:: Mean · parts per million*minutes

Change in Methane Production
parts per million*minutes	Lubiprostone	Placebo
Change in Methane Production	10645 ± 1481	14635 ± 2330

SecondaryStool Frequency (Complete Spontaneous Bowel Movements)

change in mean stool frequency (delta) between baseline week and final week of study

Time frame:: Baseline and 1 month
Reported as:: Mean · bowel movements per week

Stool Frequency (Complete Spontaneous Bowel Movements)
bowel movements per week	Lubiprostone	Placebo
Stool Frequency (Complete Spontaneous Bowel Movements)	3.71 ± 0.84	0.85 ± 0.54

SecondaryPercentage Change in the Colonic Transit Time

Percentage change of colonic transit time between the baseline colonic transit study and the colonic transit study at the end of study

Time frame:: Baseline and 1 month
Reported as:: Mean · percent

Percentage Change in the Colonic Transit Time
percent	Lubiprostone	Placebo
Percentage Change in the Colonic Transit Time	0.23 ± 0.06	0.48 ± 0.1

SecondaryPeak Methane Value

The peak methane value measured during the baseline breath study will be compared with the peak methane obtained at the end of study breath test

Time frame:: Baseline and 1 month
Reported as:: Mean · parts per million

Peak Methane Value
parts per million	Lubiprostone	Placebo
Peak Methane Value	51.3 ± 7.1	70.5 ± 11.2

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lubiprostone	—	0/29 (0%)	4/29 (13.8%)
Placebo	—	0/12 (0%)	0/12 (0%)

Most frequent other events

Most frequent other events
Event	Lubiprostone	Placebo
Chest TightnessRespiratory, thoracic and mediastinal disorders	2/29	0/12
Shortness of BreathRespiratory, thoracic and mediastinal disorders	2/29	0/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Lubiprostone	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	26	11	37
>=65 years	3	1	4

Age, Continuous
Age, Continuous(years)	Lubiprostone	Placebo	Total
Mean	42.8 ± 11.9	47.3 ± 22.5	43.7 ± 13.7

Sex: Female, Male
Sex: Female, Male(Participants)	Lubiprostone	Placebo	Total
Female	25	12	37
Male	4	0	4

Region of Enrollment
Region of Enrollment(participants)	Lubiprostone	Placebo	Total
United States	29	12	41

Study locations

2 sites

University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242, United States
University of Utah
Salt Lake City, Utah 84112, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01190020
Lead sponsor: Augusta University
Collaborators: Takeda Pharmaceuticals North America, Inc.
Responsible party: Satish Rao (PI, University of Iowa) — Principal investigator
First posted: Aug 27, 2010
Start date: Feb 2009
Primary completion: Mar 2012
Completion: Mar 2012
Results posted: Jan 15, 2019
Last update: Jan 15, 2019

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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