Botanical Tincture for Symptoms of Irritable Bowel Syndrome

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome Characterized by Constipation
• Intervention / Treatment: Drug: Botanical Tincture; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marc Brodsky, MD; Phone Number: 203-276-4777; Email: mbrodsky@stamhealth.org
• Study Contact Backup: Name: Suzanne Rose, PhD; Phone Number: 203-276-7866; Email: srose@stamhealth.org

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Stamford Health
      • Contact: Marc Brodsky, MD; Phone Number: 203-276-4777; Email: mbrodsky@stamhealth.org
      • Contact: Suzanne Rose, PhD; Phone Number: 203-276-7866; Email: srose@stamhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botanical Tincture; 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.	Drug: Botanical Tincture; 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.; Other Names: BT
Placebo Comparator: Placebo; 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.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects recruited	60 subjects	2 years
Proportion of subjects who complete the study	At least 80% subjects will complete study	12 week study
Proportion of dosages of drug/placebo that are taken by participants	At least 80% of dosages will be taken by participants	12 week study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 week study
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	12 week study
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	12 week study

Collaborators and Investigators

• Sponsor: Stamford Hospital
• Investigators: Principal Investigator: Marc Brodsky, MD, Stamford Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation
• Other Study ID Numbers: TSH_Family Medicine_2018001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No