A Double Blind, Multi-Arm, Clinical Study to Assess the Safety and Efficacy of Mool Health customized gut health regime for the Management of Constipation in subjects with Mild to Severe Constipation and Irritable Bowel Syndrome with Constipation (IBS-C)
Scientific Title of Study
A Double Blind, Multi-Arm, Clinical Study to Assess the Safety and Efficacy of a Gut
Health Regimen for the Management of Constipation in subjects with Mild to Severe Constipation and Irritable Bowel Syndrome with Constipation (IBS-C).
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
To be eligible for the study, Subjects must meet the following criteria
1.Healthy males and females aged 18–60 years.
2.Diagnosed with mild to severe functional constipation or IBS-C using Bristol stool scale.
3.Subjects willing to avoid fermented foods throughout the study duration.
4.No use of fiber supplementation over the month prior to the screening visit.
5.Able and willing to comply with the study protocol.
ExclusionCriteria
Details
Subjects with any of the following symptoms will be excluded from the study:
1.Presence of significant gastrointestinal pathology, including but not limited to malignancies.
2.Subjects with IBS-D, IBD & IBS-M.
3.Active or recent esophageal disease, such as severe gastroesophageal reflux disease (GERD) or esophageal strictures and Crohn’s, Piles disease etc.
4.Diagnosed fatty liver disease or hepatic disorders.
5.Active gastrointestinal ulcers or the recent history of peptic or duodenal ulcers.
6.Skin disorders related to immune function, such as seborrheic dermatitis.
7.History of major gastrointestinal surgery within the past 6 months.
8.Recent use of prebiotics, probiotics, Ayurvedic medications, or other supplements for constipation that significantly affect gastrointestinal motility within 2 weeks prior to screening
9.Women who are pregnant, breastfeeding, or planning pregnancy during the study period.
10.Evidence of current or recent (within the last 3 months) drug or alcohol abuse.
11.Participation in any clinical trial involving investigational products within 3 months of screening.
12.Recent history of acute or chronic illness that may compromise immune function or overall health
Method of Generating Random Sequence
Not Applicable
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
1. The change in constipation symptom severity from baseline to the end of the study period is assessed through a standardized constipation severity scale, comparing improvements in stool frequency, ease of
bowel movements, and reduction in abdominal discomfort. (VAS Scale),
2. Time frame: T0, T7, T14, T21, T28
Baseline (T0), Day 7 (T7), Day 14 (T14), Day 21 (T21), Day 28 (T28)
Secondary Outcome
Outcome
TimePoints
1.Increase in the number of bowel movements per week from baseline to the end of the study period.
2.Improvement in stool consistency as measured by the Bristol Stool Chart, comparing baseline to weekly time points
3.Subjective reports of relief from constipation symptoms, including reduced straining, bloating, and abdominal discomfort, as recorded in weekly assessments. (PAC-SYM questionnaire)
4.The incidence and severity of any adverse events or side effects associated with the gut regime, recorded throughout the study duration.
5.Time frame: T0, T7, T14, T21, T28
Time frame: T0, T7, T14, T21, T28
Target Sample Size
Total Sample Size="40" Sample Size from India="40" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This clinical study is a double-blind, multi-arm investigation aimed at evaluating the safety and efficacy of a gut health regimen for managing constipation in individuals diagnosed with mild to severe functional constipation or irritable bowel syndrome with constipation (IBS-C). Forty subjects aged 18–60, meeting specific inclusion criteria, will be enrolled. They will receive symptom-specific products targeting gut health, including probiotics, digestive aids, and stress-relief .
The primary objective is to assess the regimen’s effectiveness in reducing constipation symptoms over 30 days, with a possible extension to 56 days if necessary. Secondary objectives include monitoring changes in bowel movement frequency, stool consistency (using the Bristol Stool Chart), and participant-reported improvements in digestive health and relief from constipation. The study will also track adverse events,if any .
Outcomes will be measured through baseline and weekly assessments, using scales like the VAS for symptom severity and the PAC-SYM questionnaire for subjective symptom relief.