A Phase 2 interventional study of Colesevelam and Placebo in Chronic Diarrhea, Irritable Bowel Syndrome With Diarrhea and Bile Acid Malabsorption, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Other
To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and placebo treatment, on colonic transit, bowel functions, permeability and tight junction expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.
Compare the effects of Colesevelam versus the placebo on diabetic subjects with chronic diarrhea. In this study, diabetic subjects will get either the Colesevelam or the placebo, not both.
The plan is to have about 30 subjects complete this study at Mayo Clinic.
Exclusion Criteria:
Patients participating will not take any of the following disallowed medications for at least 7 days prior to and during the remainder of the study:
Gastrointestinal preparations:
Once randomized, subjects will have baseline testing period, treatment period, and treatment testing period the study drug. This consists of nine visits and will be over a period of five to nine weeks. Baseline testing period consists of: transit test, 4 day high fat diet with 48 hour stool collection, blood samples, rectosigmoid biopsies, one week stool diary, and medication pick up. Treatment period will have subject take the study drug 1875 mg of medication orally twice daily with lunch and supper for 4-5 weeks. The last period, is the treatment testing period. This consists of a full transit \& urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused medication.
Drug: Colesevelam
Once randomized, subjects will have a baseline testing period, treatment period and treatment testing period with the placebo. This consists of nine visits and will be over a period of five to nine weeks. The last period, is the treatment testing period. This consists of a full transit \& urine permeability test, 4 day high fat diet with 48 hour stool collection, blood samples, one week stool diary collection, and the return of the unused placebo.
Other: Placebo
Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational.
A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug.
Total Fecal Bile Acid (BA) Excretion
Total fecal BA excretion was measured using High Performance Liquid Chromatography (HPLC)/tandem mass spectrometry (MS) where single stool samples obtained at baseline and end of treatment were prepared by assay by HPLC/MS by methanol extraction and results are presented as micromoles per gram (μmoles/g) of stool.
Time frame: Treatment day 28
Stool Consistency
Stool consistency as reported by the participant via daily bowel diaries. Stool consistency was based on Bristol Stool Form Scale (BSFS) where 1 - hard lumps, 2 - lumpy sausage, 3 - cracked sausage, 4 - smooth sausage, 5 - soft lumps, 6 - mushy, and 7 - watery. Stool consistency was averaged for the 28 day treatment period.
Time frame: Treatment days 1 through 28
Number of Stools Per Day
The total number of bowel movements as reported by the participant via daily bowel diaries. The number of bowel movements were averaged for the 28 day treatment period.
Time frame: Treatment days 1 through 28
| Milestone | Colesevelam | Placebo |
|---|---|---|
| Started | 15 | 15 |
| Completed | 14 | 15 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Total fecal BA excretion was measured using High Performance Liquid Chromatography (HPLC)/tandem mass spectrometry (MS) where single stool samples obtained at baseline and end of treatment were prepared by assay by HPLC/MS by methanol extraction and results are presented as micromoles per gram (μmoles/g) of stool.
| μmoles/g | Colesevelam | Placebo |
|---|---|---|
| Total Fecal Bile Acid (BA) Excretion | 10.7 (8.2 to 17.4) | 3.6 (2.6 to 7.2) |
Stool consistency as reported by the participant via daily bowel diaries. Stool consistency was based on Bristol Stool Form Scale (BSFS) where 1 - hard lumps, 2 - lumpy sausage, 3 - cracked sausage, 4 - smooth sausage, 5 - soft lumps, 6 - mushy, and 7 - watery. Stool consistency was averaged for the 28 day treatment period.
| units on a scale | Colesevelam | Placebo |
|---|---|---|
| Stool Consistency | 4.6 (3.9 to 5.2) | 4.6 (4.3 to 5.0) |
The total number of bowel movements as reported by the participant via daily bowel diaries. The number of bowel movements were averaged for the 28 day treatment period.
| number of stools per day | Colesevelam | Placebo |
|---|---|---|
| Number of Stools Per Day | 3.1 (1.6 to 3.8) | 2.2 (1.6 to 2.9) |
Collected over Adverse events were collected for each subject from baseline to the end of the study, approximately 10 weeks, for a total study duration of approximately 18 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Colesevelam | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Placebo | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Colesevelam | Placebo | Total |
|---|---|---|---|
| Median | 44 (34 to 52) | 56 (40 to 68) | 50 (34 to 67) |
| Sex: Female, Male(Participants) | Colesevelam | Placebo | Total |
|---|---|---|---|
| Female | 11 | 13 | 24 |
| Male | 4 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Colesevelam | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 13 | 15 | 28 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Colesevelam | Placebo | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
| Body Mass Index(kg/m2) | Colesevelam | Placebo | Total |
|---|---|---|---|
| Median | 33.2 (28.0 to 37.6) | 33.6 (28.2 to 36.4) | 33.4 (28.0 to 36.7) |
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