Trial Outcomes & Findings for Crofelemer for Functional Diarrhea (NCT NCT04486326)

Last Updated: 2026-03-10

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

week 4

Results posted on

2026-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Crofelemer 125mg bid Crofelemer: Crofelemer	Placebo bid Placebo: placebo
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Crofelemer for Functional Diarrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crofelemer n=9 Participants 125mg bid Crofelemer: Crofelemer	Placebo n=8 Participants bid Placebo: placebo	Total n=17 Participants Total of all reporting groups
Age, Customized years	45 years old STANDARD_DEVIATION 15 • n=68 Participants	35 years old STANDARD_DEVIATION 8 • n=69 Participants	40 years old STANDARD_DEVIATION 15 • n=137 Participants
Sex: Female, Male Female	3 Participants n=68 Participants	2 Participants n=69 Participants	5 Participants n=137 Participants
Sex: Female, Male Male	6 Participants n=68 Participants	6 Participants n=69 Participants	12 Participants n=137 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Race (NIH/OMB) Asian	0 Participants n=68 Participants	1 Participants n=69 Participants	1 Participants n=137 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Race (NIH/OMB) Black or African American	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Race (NIH/OMB) White	9 Participants n=68 Participants	7 Participants n=69 Participants	16 Participants n=137 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants

PRIMARY outcome

Timeframe: week 4

Outcome measures

Outcome measures
Measure	Crofelemer n=9 Participants 125mg bid Crofelemer: Crofelemer	Placebo n=8 Participants bid Placebo: placebo
Consistency of Stool at Week 4	5.28 score on a scale Standard Deviation 0.72	5.85 score on a scale Standard Deviation 0.79

Adverse Events

Crofelemer

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Crofelemer n=9 participants at risk 125mg bid Crofelemer: Crofelemer	Placebo n=8 participants at risk bid Placebo: placebo
Infections and infestations Upper Respiratory Illness	11.1% 1/9 • Number of events 1 • 8 weeks	12.5% 1/8 • Number of events 1 • 8 weeks

Additional Information

Judy Nee

BIDMC

Phone: 617-667-2193

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place