Trial Outcomes & Findings for Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients (NCT NCT03898856)

NCT ID: NCT03898856

Last Updated: 2026-02-12

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

93 participants

Primary outcome timeframe

Week 1

Results posted on

2026-02-12

Participant Flow

Of the 93 participants enrolled, 23 met the inclusion criteria and continued in the study to receive the intervention.

Participant milestones

Participant milestones
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Overall Study STARTED	93
Overall Study Received Intervention	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	70

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea n=23 Participants 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=41 Participants
Age, Categorical >=65 years	7 Participants n=41 Participants
Sex: Female, Male Female	17 Participants n=41 Participants
Sex: Female, Male Male	6 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	2 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	3 Participants n=41 Participants
Race (NIH/OMB) White	18 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Region of Enrollment United States	23 participants n=41 Participants

PRIMARY outcome

Timeframe: Week 1

Outcome measures

Outcome measures
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea n=23 Participants 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Number of Participants With a 50 Percent Decrease in Mean Stool Count	17 Participants

PRIMARY outcome

Timeframe: Week 2

Outcome measures

Outcome measures
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea n=23 Participants 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Number of Participants With a 50 Percent Decrease in Mean Stool Count	16 Participants

PRIMARY outcome

Timeframe: Week 3

Outcome measures

Outcome measures
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea n=23 Participants 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Number of Participants With a 50 Percent Decrease in Mean Stool Count	18 Participants

PRIMARY outcome

Timeframe: Week 4

Outcome measures

Outcome measures
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea n=23 Participants 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Number of Participants With a 50 Percent Decrease in Mean Stool Count	17 Participants

SECONDARY outcome

Timeframe: week 4

The Bristol stool form scale is a validated 1-7 scale that correlates to stool form. Type 1 is pebble like stool, type 2 lumpy and hard, type 3 like a sausage with cracks on the surface type 4 like a sausage but smooth and soft, type 5 soft blobs with clear cut edges, type 6 fluffy pieces with ragged edges, mushy stool, type 7watery, no solid pieces Types 5-7 are consistent with diarrhea and for this study a movement to lower types is considered an improvement

Outcome measures

Outcome measures
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea n=23 Participants 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Number of Participants With an Improvement in Stool Consistency by More Than 2 Levels as Measured by the Bristol Stool Form Scale	18 Participants

SECONDARY outcome

Timeframe: Baseline,week 4 of treatment

Population: Data were only collected from participants who completed the questionnaire.

Health-related quality of life questionnaire assesses psychological, and social functioning. The total score ranges from 0 to 100 with higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea n=16 Participants 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire Week 4	61.8 score on a scale Standard Deviation 8.75
Physical, Psychological, and Social Functioning as Measured by the Health-related Quality of Life (HRQOL) Questionnaire Baseline	63.8 score on a scale Standard Deviation 9.32

SECONDARY outcome

Timeframe: Baseline

Population: Data were not collected for 5 participants because required laboratory assessments were not performed.

Outcome measures

Outcome measures
Measure	Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea n=88 Participants 125 mg tablets taken by mouth twice daily for 28 days Crofelemer: 125 mg tablets taken by mouth twice daily for 28 days Diagnostic tests for cause of chronic diarrhea: Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
Number of Participants With Any Abnormal Diagnostic Test Results Leading to the Identification of the Cause of Chronic Diarrhea	12 Participants

Adverse Events

Crofelemer and Diagnostic Tests for Cause of Chronic Diarrhea

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brooks Cash, MD

The University of Texas Health Sciences Center at Houston

Phone: 713-500-6677

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place