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Botanical Tincture for Symptoms of Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome Characterized by Constipation

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Botanical Tincture

Placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome Characterized by Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients meeting ROME IV criteria for the diagnosis of irritable bowel syndrome that requires that patients have had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with 2 or more of the following :
Related to defecation (may be increased or unchanged by defecation)
Associated with a change in stool frequency
Associated with a change in stool form or appearance
Abdominal Pain Intensity: average of worst daily (in past 24 hours) abdominal pain score of >= 3 on a 0 to 10 point scale over last week
Stool Frequency: < or = to 3 Complete Spontaneous Bowel Movement(CSBM) in the previous week
Reported bloating rating > or = 2 on 5-point scale [0 (absent) - 4 (very severe)] in previous week
English speakers, as all surveys are in English

Exclusion Criteria:

Patients with known hypersensitivity to any component of the trial drugs
History of eating disorders
Patients with a history of diseases with abdominal symptoms that can resemble IBS
Presence of any other known acute or chronic gastrointestinal disorder
History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously)
Pregnancy or breast feeding
Current or past history of alcohol dependence
Based on lack of adequate scientific evidence to predict drug-drug interaction in vivo, current use of strong inhibitors or inducers for CYP enzymes and participants are instructed not to take any medications that are strong inhibitors or inducers for CYP enzymes during the course of the study
Vulnerable Subjects. The study will not include vulnerable subjects (such as, those with limited autonomy or those in subordinate hierarchical positions). Children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity will not be included.

Sites / Locations

Stamford Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botanical Tincture

Placebo

Arm Description

The 12-week study includes a 2-week screening, 8-week treatment, and 2-week withdrawal periods. A 2-week screening period will be used to establish the presence and persistence of trial entry criteria and train patients in the mode of data collection. Participants randomly assigned to the Botanical Tincture arm at Week 2 will take 2.5 ml by mouth once a day at any time during the day that they choose. Participants who received Botanical Tincture during the study will be followed by a 2-week randomized withdrawal design to address the need for maintenance treatment to prevent sign or symptom recurrence. The participant will be randomly reassigned to receive either Botanical Tincture or placebo at a dosage of 2.5 ml once a day by mouth at any time during the day that they prefer.

Participants randomly assigned to placebo arm at Week 2 will take 2.5 ml by mouth once a day at any time during the day that they choose during the 8-week treatment period.

Outcomes

Primary Outcome Measures

Number of subjects recruited

60 subjects

Proportion of subjects who complete the study

At least 80% subjects will complete study

Proportion of dosages of drug/placebo that are taken by participants

At least 80% of dosages will be taken by participants

Secondary Outcome Measures

Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain)

An Abdominal Pain Intensity Weekly Responder is defined as a patient who experiences a decrease in the weekly average of worst abdominal pain in the past 24 hours score (measured daily) of at least 30% compared with baseline weekly average.

Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe)

A Bloating Intensity Weekly Responder is defined as a patient who experiences a decrease in the weekly average of worst bloating pain in the past 24 hours score (measured daily) of at least 30% compared with baseline weekly average

Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week

A Stool Frequency Weekly Responder is defined as a patient who experiences an increase of at least one CSBM per week from baseline

Full Information

NCT ID

NCT03923322

First Posted

April 17, 2019

Last Updated

April 11, 2023

Sponsor

Stamford Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03923322

Brief Title

Botanical Tincture for Symptoms of Irritable Bowel Syndrome

Official Title

Randomized Pilot Trial of Botanical Tincture for Symptoms of Irritable Bowel Syndrome Constipation Predominant (IBS-C) Diagnosed on ROME IV Criteria

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2023 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stamford Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to investigate the feasibility of a follow-up larger RCT on the efficacy of Botanical Tincture to relieve abdominal pain in people with Irritable Bowel Syndrome Constipation Predominant (IBS-C).

Detailed Description

The randomized pilot trial will address subject recruitment, retention, and subject compliance with protocol. A secondary is to learn if people with IBS-C are able to tolerate Botanical Tincture and the effect of taking Botanical Tincture on abdominal pain, bloating, and bowel movements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome Characterized by Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Double-blinded randomized, placebo-controlled trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Botanical Tincture

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants randomly assigned to placebo arm at Week 2 will take 2.5 ml by mouth once a day at any time during the day that they choose during the 8-week treatment period.

Intervention Type

Drug

Intervention Name(s)

Botanical Tincture

Other Intervention Name(s)

Intervention Description

Study participants will meet with the Investigator at baseline and week 2, 6, and 10 after the study period begins. Trial continuation criteria at 2 weeks after the start of the study includes abdominal pain intensity and stool frequency. Participants randomized to Botanical Tincture will have a 2-week withdrawal period. On the visits study participants may expect to be asked about epidemiologic information, IBS medications, IBS Quality of Life survey instruments, and daily diary of pain scale, bloating scale, and number of bowel movements.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Study participants will meet with the Investigator at baseline and week 2, 6, and 10 after the study period begins. Trial continuation criteria at 2 weeks after the start of the study includes abdominal pain intensity and stool frequency. On the visits study participants may expect to be asked about epidemiologic information, IBS medications, IBS Quality of Life survey instruments, and daily diary of pain scale, bloating scale, and number of bowel movements.

Primary Outcome Measure Information:

Title

Number of subjects recruited

Description

60 subjects

Time Frame

2 years

Title

Proportion of subjects who complete the study

Description

At least 80% subjects will complete study

Time Frame

12 week study

Title

Proportion of dosages of drug/placebo that are taken by participants

Description

At least 80% of dosages will be taken by participants

Time Frame

12 week study

Secondary Outcome Measure Information:

Title

Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain)

Description

Time Frame

12 week study

Title

Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe)

Description

Time Frame

12 week study

Title

Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week

Description

A Stool Frequency Weekly Responder is defined as a patient who experiences an increase of at least one CSBM per week from baseline

Time Frame

12 week study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients meeting ROME IV criteria for the diagnosis of irritable bowel syndrome that requires that patients have had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with 2 or more of the following : Related to defecation (may be increased or unchanged by defecation) Associated with a change in stool frequency Associated with a change in stool form or appearance Abdominal Pain Intensity: average of worst daily (in past 24 hours) abdominal pain score of >= 3 on a 0 to 10 point scale over last week Stool Frequency: < or = to 3 Complete Spontaneous Bowel Movement(CSBM) in the previous week Reported bloating rating > or = 2 on 5-point scale [0 (absent) - 4 (very severe)] in previous week English speakers, as all surveys are in English Exclusion Criteria: Patients with known hypersensitivity to any component of the trial drugs History of eating disorders Patients with a history of diseases with abdominal symptoms that can resemble IBS Presence of any other known acute or chronic gastrointestinal disorder History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously) Pregnancy or breast feeding Current or past history of alcohol dependence Based on lack of adequate scientific evidence to predict drug-drug interaction in vivo, current use of strong inhibitors or inducers for CYP enzymes and participants are instructed not to take any medications that are strong inhibitors or inducers for CYP enzymes during the course of the study Vulnerable Subjects. The study will not include vulnerable subjects (such as, those with limited autonomy or those in subordinate hierarchical positions). Children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity will not be included.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marc Brodsky, MD

Phone

203-276-4777

mbrodsky@stamhealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Suzanne Rose, PhD

Phone

203-276-7866

srose@stamhealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Brodsky, MD

Organizational Affiliation

Stamford Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stamford Health

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Brodsky, MD

Phone

203-276-4777

mbrodsky@stamhealth.org

First Name & Middle Initial & Last Name & Degree

Suzanne Rose, PhD

Phone

203-276-7866

srose@stamhealth.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD will be available from Marc Brodsky, MD

IPD Sharing Time Frame

Data will be available after publication for unlimited time

IPD Sharing Access Criteria

Researcher

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