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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Botanical Tincture for Symptoms of Irritable Bowel Syndrome

Clinicaltrials.gov identifier NCT03923322

Recruitment Status Not yet recruiting

First Posted April 22, 2019

Last update posted March 18, 2020

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).

  • Condition or Disease:Irritable Bowel Syndrome Characterized by Constipation
  • Intervention/Treatment: Drug: Botanical Tincture
    Other: Placebo
  • Phase: Phase 2
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Double-blinded randomized, placebo-controlled trial
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Randomized Pilot Trial of Botanical Tincture for Symptoms of Irritable Bowel Syndrome Constipation Predominant (IBS-C) Diagnosed on ROME IV Criteria
  • Estimated Study Start Date: September 2020
  • Estimated Primary Completion Date: September 2022
  • Estimated Study Completion Date: January 2023
Arms and interventions
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Number of subjects recruited [ Time Frame: 2 years ]
    60 subjects
  • 2. Proportion of subjects who complete the study [ Time Frame: 12 week study ]
    At least 80% subjects will complete study
  • 3. Proportion of dosages of drug/placebo that are taken by participants [ Time Frame: 12 week study ]
    At least 80% of dosages will be taken by participants
  • Secondary Outcome Measures: 1. Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain) [ Time Frame: 12 week study ]
    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.
  • 2. Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe) [ Time Frame: 12 week study ]
    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
  • 3. Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week [ Time Frame: 12 week study ]
    A Stool Frequency Weekly Responder is defined as a patient who experiences an increase of at least one CSBM per week from baseline
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 = 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.

Contacts and Locations
Contacts

Contact: Marc Brodsky, MD 203-276-4777 mbrodsky@stamhealth.org

Contact: Suzanne Rose, PhD 203-276-7866 srose@stamhealth.org

Locations

United States, Connecticut
Stamford Health
Stamford

Sponsors and Collaborators

Stamford Hospital

Investigators

Principal Investigator: Marc Brodsky, MD Stamford Hospital

More Information
  • Responsible Party: Stamford Hospital
  • ClinicalTrials.gov Identifier: NCT03923322 History of Changes
  • Other Study ID Numbers: TSH_Family Medicine_2018001
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: March 18, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: IPD will be available from Marc Brodsky, MD
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: Data will be available after publication for unlimited time
  • Access Criteria: Researcher
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Irritable Bowel Syndrome
    Syndrome
    Constipation