Trial · NCT04486326
Crofelemer for Functional Diarrhea
NCT04486326, Phase 4, Terminated, Beth Israel Deaconess Medical Center; results first posted 2026-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Crofelemer for Functional Diarrhea. Trials, record NCT04486326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04486326
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Crofelemer for Functional Diarrhea
- NCT number
- NCT04486326
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 17 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Diarrhea
- Interventions
- Crofelemer, Placebo
- First posted
- 2020-07-24
- Last updated
- 2026-03-10
- Results first posted
- 2026-03-10
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Consistency of Stool at Week 4 | week 4 | Average stool consistency score on the scale from 1 to 7 (from Bristol stool form scale (BSFS)). This rates the stool consistency by type from 1-7. BSFS 1 indicates hard stool consistent with constipation, whereas BSFS of 7 indicates loose, watery stool consistent with diarrhea. Therefore, in this study, a higher score indicates more diarrhea/worse outcome |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Consistency of Stool at Week 4 | week 4 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Consistency of Stool at Week 4 | Crofelemer | 5.28 | Standard Deviation 0.72 | score on a scale | |
| Consistency of Stool at Week 4 | Placebo | 5.85 | Standard Deviation 0.79 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crofelemer | 9 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Crofelemer | 9 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Crofelemer | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper Respiratory Illness | Infections and infestations | Crofelemer | 1 | 9 | 1 |
| other | Upper Respiratory Illness | Infections and infestations | Placebo | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crofelemer | 0 | 9 |
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, other adverse events | Crofelemer | 1 | 9 |
| Total, other adverse events | Placebo | 1 | 8 |
| Total, serious adverse events | Crofelemer | 0 | 9 |
| Total, serious adverse events | Placebo | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Crofelemer vs Placebo: deaths from any cause | Trial comparisons |
| Crofelemer vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04486326
GET https://conductscience.org/api/trials/v1/NCT04486326/registered