Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Lactitol 5 g + flaxseed mucilage 2.5 g: 15 mL to be consumed orally daily at night for 28 days. The study product will be dispensed to the subjects, and they will be instructed on the p
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who meet all the following criteria will be included in the study. 2. Male or female subjects aged 18 years or above. 3. Subjects willing to provide informed consent and adhere to the study procedures. 4. Subject diagnosed with CIC as per Rome IV criteria and having two or more of the following. a. Straining during more than (25%) of defecations b. Lumpy or hard stools (BSFS type 1-2) more than (25%) of defecations c. Sensation of incomplete evacuation more than (25%) of defecations d. Sensation of anorectal obstruction/blockage more than (25%) of defecations e. Manual maneuvers to facilitate more than (25%) of defecations (e.g. digital evacuation support of the pelvic floor) f. Fewer than three SBM per week g. Loose stools are rarely present without the use of laxatives h. Insufficient criteria for irritable bowel syndrome (IBS) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
Exclusion criteria
Exclusion criteria: 1. Subjects with constipation due to IBS or opioid use. 2. Subjects with organic gastrointestinal disorders (e.g. inflammatory bowel disease colorectal cancer). 3. Subjects using any other laxatives or probiotics or fiber supplements like Isabgol or prebiotic fibers in the 2 weeks prior to screening or currently using any formulation/ over the counter drugs/ Ayurvedic medicine 4. Comorbidities like CKD long standing and uncontrolled diabetes 5. Subjects are being treated for hypothyroidism but the dose of medication has not been stable for at least 3 months at the time of Screening. 6. History of hypersensitivity or allergy to active substance and/or any of the study medication ingredients viz. lactitol or flaxseed mucilage. 7. Pregnant, Lactating mothers. 8. Subjects who will be traveling during the study period and will be unavailable for clinical follow-up visits. 9. Subjects on restrictive diets or crash diets like ketogenic intermittent fasting detox diets. 10. Subjects with a history of intestinal or colonic obstruction or suspected intestinal obstruction. 11. Subjects with a history of complicates/obstructive diverticular disease. 12. Subjects having any intestinal/rectal prolapse or other known pelvic floor dysfunction 13. Subjects with any clinical evidence of significant respiratory cardiovascular renal hepatic biliary endocrine psychiatric or neurologic disease. 14. Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subjects ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Lactitol-FSM, at two dose ratios, in terms of SBMs To evaluate the safety of Lactitol-FSM, at two dose ratios, in terms of treatment emergent adverse event (TEAE), adverse event of special interest (AESI) of flatulence To compare the efficacy and safety of Lactitol-FSM versus Lactitol aloneTimepoint: Baseline (Day-1), Day-7, Day-14, Day-28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess 24-hour dietary recall to characterize the dietary intake of the subjectsTimepoint: Baseline (Day-1) & Day-28 | — |
Countries
India
Contacts
Public ContactDr Sagar Katare
Dr. Reddys Laboratories Limited
Outcome results
None listed