None listed
Conditions
Interventions
None listed
Sponsors
ITC Life Science and Technology center
Eligibility
Inclusion criteria
Inclusion criteria: 1.Elderly with digestive complaints (Bowel Function)} - Male or Female Age 55-65 years. (E.g. Documented History of Chronic Constipation, IBS, Diarrhea, Stomach pain etc. (For Group â??A ) 2. Constipated Subjects (complaints of hard and lumpy stools) â?? Male or Non-pregnant Female Age 18- 50 years ( For Group â?? B ) 3. Healthy subjects (as defined by medical history & physical examination)-male or non-pregnant female â?? Age 18- 50 years (For Group C ) 4. Rome-III diagnostic criteria prescribed for IBS. (For Group â?? B) (Annexure I) 5.Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with changes in frequency of stool. (Group-B) 6.Relief of pain or discomfort with defecation. (Group â?? B) 7. Capability to provide written informed consent (For all Groups)
Exclusion criteria
Exclusion criteria: 1.The subject has a serious, unstable medical condition,such as lung disease,uncontrolled blood pressure,uncontrolled thyroid function,a physical or medical disability or an advanced medical condition. 2.The subject had previous significant gastric or intestinal surgery except appendectomy and gall bladder surgery. 3.IBS sub type other than IBS associated with Constipation. 4.Diarrhea more than 3 bowel movements per day. 5.Antibiotic use within 4 weeks of randomization. 6.Pregnant or lactating women. 7.Subjects on the ongoing therapies with the drugs known to effect gut motility e.g. Laxatives, prokinetics, etc. 8.Subject with eating disorder. 9.History of alcohol, drug, or medication abuse. 10.Participation in another study with any investigational product (IP) within 3 months of randomization. 11.Subject with any condition that might interfere with the conduct of the study as per Investigatorâ??s opinion. 12.Known allergies to any substance in the study product, including lactose intolerance and galactosemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Assessment of Bowel function , stool frequency and consistency, PH, fecal questionerTimepoint: Group A Day 1, Day 14, Day 60, Day 75 Group B&C Day 1, Day 14, Day 28, Day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Bowel function-stool frequency and consistency â?¢ Microflora composition (Lactobacilli, Bifidobacteria) â?¢ Fecal calprotectin â?¢ Abdominal symptoms â?¢ The Quality of Life Scale (QOLS) â?¢ POMS Based assessment â?¢ Physiological assessment for health/ clinical markers(BMI, calf circumference and mid arm circumference Timepoint: Group A Day 1, Day 14, Day 60, Day 75 Group B&C Day 1, Day 14, Day 28, Day 43 | — |
Countries
India
Contacts
Public ContactDr Ajay Kumar Gupta
Meenakshi Hospital
Outcome results
None listed