Trial · NCT04150250

Cholera Anti-Secretory Treatment Trial

NCT04150250, Phase 2, Completed, PATH; results first posted 2021-03-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cholera Anti-Secretory Treatment Trial. Trials, record NCT04150250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04150250

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cholera Anti-Secretory Treatment Trial
NCT number: NCT04150250
Status: Completed
Phases: Phase 2
Enrollment: 47 participants, actual
Lead sponsor: PATH
Conditions: Cholera
Interventions: iOWH032, Placebo, V. cholerae Challenge, Antibiotics
First posted: 2019-11-04
Last updated: 2021-03-25
Results first posted: 2021-03-25

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Diarrheal Stool Output Rate	Day 1 - Day 5 (up to first dose of antibiotic therapy)	Diarrheal stool output rate is defined as the total volume of diarrheal stools (in mL, Grade 3 and above) divided by the number of hours between initiation of study drug (iOWH032 or placebo) and initiation of antibiotic therapy. Stools were graded based on consistency as follows: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) The definition of diarrhea is a grade 3 or higher stool.
Primary	Diarrheal Stool Output Rate Including Participants With Symptom Onset After 48 Hours	Day 1 - Day 5 (up to first dose of antibiotic therapy)	Stools were graded based on consistency as follows: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) The definition of diarrhea is a grade 3 or higher stool. For participants with symptom onset within 48 hours of challenge diarrheal stool output rate is defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between initiation of study product dosing and initiation of antibiotic therapy. For participants with symptom onset after 48 hours diarrheal stool output rate is defined as the total volume of diarrheal stools (mL, Grade 3 and above) divided by the number of hours between onset of symptoms and initiation of antibiotic therapy.
Primary	Number of Participants With Treatment-emergent Serious Adverse Events	Day 1 - Day 180	A serious adverse event (SAE) is any adverse event that resulted in any of the following outcomes: 1. Death 2. A life-threatening event. 3. Required inpatient hospitalization or prolongation of existing hospitalization 4. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. Congenital abnormality or birth defect 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or requires medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event.
Secondary	Percentage of Participants With Moderate to Severe Diarrhea With Onset Within 48 Hours Following Cholera Challenge	Day 1 - Day 5 (up to first dose of antibiotic therapy)	The percentage of participants with moderate to severe diarrhea with onset within 48 hours following cholera challenge. Diarrhea was defined as a grade 3 or higher stool based on the following scale: * Grade 1 - well formed (normal stool, does not take the shape of the container) * Grade 2 - soft (normal stool, does not take the shape of the container) * Grade 3 - thick liquid (diarrhea, takes the shape of the container readily) * Grade 4 - opaque watery diarrhea * Grade 5 - rice water diarrhea (clear watery) Diarrheal stools (Grade 3-5) were graded for severity according to the following: Mild: ≤ 3 liters loose stools; Moderate: \> 3 liters loose stools; Severe: \> 5 liters loose stools.
Secondary	Attack Rate of Any Diarrhea Following Cholera Challenge	Day 1 - Day 5 (up to first dose of antibiotic therapy)	Attack rate of any diarrhea following cholera challenge is defined as the number of participants with 2 or more loose stools (Grade 3-5) totaling \> 200 mL or 1 loose (Grade 3-5) stool \> 300 mL, respectively, with onset within 48 hours of cholera challenge.
Secondary	Area Under the Curve (AUC) of Diarrheal Stool Volume Between Challenge Dose and Initiation of Antibiotics	Day 1 to Day 5 (prior to first dose of antibiotic)	The AUC of diarrheal stool volume and cholera organisms was computed via the trapezoidal rule.
Secondary	Peak Shedding of Cholera Organisms	Day 1 to Day 5 (prior to first dose of antibiotic)	Quantitative cultures were performed on the first two stool samples of each 24-hour period prior to the initiation of antibiotics to determine the number of cholera organisms per gram of stool. Peak shedding represents the highest colony-forming unit (CFU) counts observed for each participant.
Secondary	Duration of Diarrheal Episodes	Day 1 to Day 5 (prior to first dose of antibiotics)	Duration of diarrheal episodes was calculated using Kaplan-Meier methods as the time from cholera challenge to the time of the first formed stool (Grade 1), after which all following stools were also formed.
Secondary	Total Number of Loose (Grade 3-5) Stools	Day 1 to Day 5 (prior to first dose of antibiotic therapy)	Total number of loose stools (Grade 3 and above) per participant during the interval immediately following challenge and prior to initiation of antibiotic therapy.
Secondary	Percentage of Participants With Fever Following Cholera Challenge	Day 1 to Day 5, prior to first dose of antibiotics	The presence of fever was defined as a body temperature of ≥ 39°C (102.1°F).

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Diarrheal Stool Output Rate	Day 1 - Day 5 (up to first dose of antibiotic therapy)	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.	mL/hour	MEDIAN
PRIMARY	Diarrheal Stool Output Rate Including Participants With Symptom Onset After 48 Hours	Day 1 - Day 5 (up to first dose of antibiotic therapy)	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) after challenge.	mL/hour	MEDIAN
PRIMARY	Number of Participants With Treatment-emergent Serious Adverse Events	Day 1 - Day 180	All participants who received any study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants With Moderate to Severe Diarrhea With Onset Within 48 Hours Following Cholera Challenge	Day 1 - Day 5 (up to first dose of antibiotic therapy)	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.	percentage of participants	NUMBER
SECONDARY	Attack Rate of Any Diarrhea Following Cholera Challenge	Day 1 - Day 5 (up to first dose of antibiotic therapy)	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.	percentage of participants	NUMBER
SECONDARY	Area Under the Curve (AUC) of Diarrheal Stool Volume Between Challenge Dose and Initiation of Antibiotics	Day 1 to Day 5 (prior to first dose of antibiotic)	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.	liters * hours	MEDIAN
SECONDARY	Peak Shedding of Cholera Organisms	Day 1 to Day 5 (prior to first dose of antibiotic)	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.	CFU/g	MEAN
SECONDARY	Duration of Diarrheal Episodes	Day 1 to Day 5 (prior to first dose of antibiotics)	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.	hours	MEDIAN
SECONDARY	Total Number of Loose (Grade 3-5) Stools	Day 1 to Day 5 (prior to first dose of antibiotic therapy)	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.	loose stools	MEDIAN
SECONDARY	Percentage of Participants With Fever Following Cholera Challenge	Day 1 to Day 5, prior to first dose of antibiotics	Randomized participants who received at least one dose of study drug (iOWH032 or placebo) and with indication of cholera infection (diarrheal stool output of Grade 3 or higher) within 48 hours of challenge.	percentage of participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Diarrheal Stool Output Rate	iOWH032	25.42	Inter-Quartile Range 7.2 to 65.9	mL/hour
Diarrheal Stool Output Rate	Placebo	32.57	Inter-Quartile Range 14.7 to 53.0	mL/hour
Diarrheal Stool Output Rate Including Participants With Symptom Onset After 48 Hours	iOWH032	25.42	Inter-Quartile Range 6.3 to 63.8	mL/hour
Diarrheal Stool Output Rate Including Participants With Symptom Onset After 48 Hours	Placebo	29.22	Inter-Quartile Range 12.5 to 49.6	mL/hour
Number of Participants With Treatment-emergent Serious Adverse Events	iOWH032	0		Participants
Number of Participants With Treatment-emergent Serious Adverse Events	Placebo	1		Participants
Percentage of Participants With Moderate to Severe Diarrhea With Onset Within 48 Hours Following Cholera Challenge	iOWH032	43.8	95% Confidence Interval 19.8 to 70.1	percentage of participants
Percentage of Participants With Moderate to Severe Diarrhea With Onset Within 48 Hours Following Cholera Challenge	Placebo	55.0	95% Confidence Interval 31.5 to 76.9	percentage of participants
Attack Rate of Any Diarrhea Following Cholera Challenge	iOWH032	93.8	95% Confidence Interval 69.8 to 99.8	percentage of participants
Attack Rate of Any Diarrhea Following Cholera Challenge	Placebo	100.0	95% Confidence Interval 83.2 to 100.0	percentage of participants

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	iOWH032	23
Overall Study	STARTED	Placebo	24
Overall Study	COMPLETED	iOWH032	23
Overall Study	COMPLETED	Placebo	22
Overall Study	NOT COMPLETED	iOWH032	0
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events96

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
other	Nausea	Gastrointestinal disorders	iOWH032	6	23
other	Nausea	Gastrointestinal disorders	Placebo	5	24
other	Diarrhoea	Gastrointestinal disorders	iOWH032	5	23
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	24
other	Vomiting	Gastrointestinal disorders	iOWH032	1	23
other	Vomiting	Gastrointestinal disorders	Placebo	6	24
other	Abdominal discomfort	Gastrointestinal disorders	iOWH032	4	23
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	2	24
other	Abdominal pain	Gastrointestinal disorders	iOWH032	2	23
other	Abdominal pain	Gastrointestinal disorders	Placebo	4	24

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	iOWH032	0	23
Total, all-cause mortality	Placebo	0	24
Total, other adverse events	iOWH032	18	23
Total, other adverse events	Placebo	21	24
Total, serious adverse events	iOWH032	0	23
Total, serious adverse events	Placebo	1	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34793441	DERIVED

Source PubMed

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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
iOWH032 vs Placebo: Number of Participants With Treatment-emergent Serious Adverse Events	Trial comparisons
iOWH032 vs Placebo: deaths from any cause	Trial comparisons
iOWH032 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04150250

GET https://conductscience.org/api/trials/v1/NCT04150250/results?page=2

API reference For AI assistants