Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Lactogred-Lactulose & Synbiotic – 25ml: Subjects will be instructed to consume orally approximately 25 mL of test product, daily at night for 28 days
Control Intervention1: Lactulose -
Sponsors
Dr Reddys Laboratories
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male or female subjects with age of 18-65 years (both years inclusive). 2)Subject diagnosed with functional constipation/chronic constipation as per Rome IV criteria is two or more of the following: a) Straining during more than ¼ (25%) of defecations b) Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations c) Sensation of incomplete evacuation more than ¼ (25%) of defecations d) Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations e) Manual maneuvers to facilitate more than ¼ (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 3)Subject must be willing and able to administer the study medication as directed, comply with study instructions and commit to all subsequent visits for the duration of the study. 4) Subject who agrees to refrain from making any new, major life-style changes that may have affected constipation symptoms (e.g., starting a new diet, fasting for prolonged duration during study period or changing his or her exercise pattern) from the time of signature of the ICF to the last trial visit. 5) Subject having good general health and free of any disease state or physical condition that might impair evaluation of constipation or which in the Investigators opinion exposes the subject to an unacceptable risk by study participation. 6) Subject and/or LAR willing to give their written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Female subject who is pregnant, lactating or planning to become pregnant during the study. 2.Subject with history of diabetes. 3.Subject with history of hypersensitivity or allergy to active substance and/or any of the study medication ingredients. 4.Subject who have previously undergone any major abdominal surgery. 5.Subject with documented history of slow colonic transit. 6.Subject currently having any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance. 7.Subject having clinical features suggestive of alarming symptoms (e.g., rectal bleeding, weight loss etc.). 8.Subject having family history of peptic ulcer, colorectal cancer or IBD, Abnormal laboratory data or thyroid function. 9.Subject who has used any fiber supplement/laxative/probiotic in the 2 weeks prior to screening or currently using any formulation/ over the counter drugs/ Ayurvedic medicine or following crash diets- intermittent fasting or ketogenic diets. 10.Subject with a structural abnormality of the gastrointestinal (GI) tract or a disease or history of a condition that could affect GI motility. 11.Subject who previously had a fecal impaction that required hospitalization or emergency room treatment, or had a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction (unless successful treatment had been documented by a normal balloon expulsion test). 12.Subject with an acute or chronic condition that, in the investigator’s opinion, would limit the subject’s ability to participate or complete in this study. 13.Subject who has an unstable medical or psychological condition(s) evident prior during screening or that could, in the Investigator’s opinion, be exacerbated during the course of the study. 14.Subject with a recent history (during the 12 months before the Randomization Visit) of drug or alcohol abuse. 15.Subject who has used an Investigational drug in any form or participated in any clinical trial within 30 days prior to first administration of the study medication. 16.Subject who is institutionalized. 17.Subject who lives in the same household as currently enrolled subject. 18.Subject with presence of any other medical condition or abnormal conditions that might adversely impact the safety of the study subjects or confound the study results. 19.For Microbiome cohort - exclude subjects on antibiotics within the last 4 weeks, on probiotics/prebiotics/high fibre supplements for 4-6 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment success (defined as 3 or more spontaneous stools per week) 2. Change from baseline in weekly frequency of Spontaneous Bowel Movement (SBM)Timepoint: 1. Number of stools at baseline (Day 01), Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)]. 2. Change from baseline (Day 01) to Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days)] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subject with complete spontaneous bowel movement (CSBM) 2. Proportion of subject with an SBM within 24 hours after the first dose of study drug. 3. Median time to first CSBM. 4. Change from baseline in stool consistency using Bristol Stool Form Scale (BSFS). 5. Change from Baseline in Weekly Degree of Straining of SBMs 6. Change from Baseline in Weekly Abdominal Bloating Score 7. Change from Baseline in Weekly Abdominal Discomfort Score 8. Difficulty in degree of defecation-sensation of incomplete evacuation 9. Proportion of subject with decrease of at least 30 percentage in Abdominal Pain (AP) scale from baseline. 10. Quality of Life – Modified Patient Assessment of Constipation Quality of Life PAC QOL 11. 3-day Dietary recall by Dietician 12. Food Frequency Questionnaire (FFQ) - Probiotic Foods 13. Gut Microbiota AssessmentTimepoint: Change from baseline (Day 01) to Day 8 (± 2 days), Day 15 (± 2 days), Day 22 (± 2 days) and Day 29 (± 4 days) | — |
Countries
India
Contacts
Public ContactDr Rachana M Bhoite
Dr. Reddys Laboratories
Outcome results
None listed