Botanical Tincture for Symptoms of Irritable Bowel Syndrome

Irritable Bowel Syndrome Characterized by Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03923322
• Other study ID #: TSH_Family Medicine_2018001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2023
• Est. completion date: January 2025

Study information

• Verified date: April 2023
• Source: Stamford Hospital
• Contact: Marc Brodsky, MD
• Phone: 203-276-4777
• Email: mbrodsky[@]stamhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome Characterized by Constipation
• Syndrome

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Stamford Health	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Stamford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects recruited	60 subjects	2 years
Primary	Proportion of subjects who complete the study	At least 80% subjects will complete study	12 week study
Primary	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	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
Secondary	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
Secondary	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