Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: VL-BK-02: One capsule to be taken orally once day before breakfast For 84 Days
Control Intervention1: Placebo: One capsule to be taken orally once day before breakfast For 84 days
Sponsors
Vedic Lifesciences Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants agreed to the signed and dated informed consent form. 2.Male and female individuals of age between 18 to 60 years. 3.Individuals who meet Rome IV diagnostic criteria for functional constipation as indicated by the criteria fulfilled for the last 3 months with symptoms onset at least 6 months prior to diagnosis: i.Must include two or more of the following criteria: a)Fewer than three SBMs per week b) Straining during more than (25%) of defecations c) Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than (25%) of defecations d) Sensation of incomplete evacuation more than (25%) of defecations e) Sensation of anorectal obstruction/ blockage more than (25%) of defecations f) Manual maneuvers to facilitate more than (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) ii.Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome 4. Individuals willing to comply with all study procedures and availability for the duration of the study as per the protocol. 5. Individuals willing to maintain the same dietary and physical activity practices throughout the study period. 6. Individuals with fewer than three CSBMs per week.
Exclusion criteria
Exclusion criteria: 1. Individuals with well-known, organic cause of constipation (Polyps, hemorrhoids, etc.) 2. Individuals with anorectal pathology. 3. Individuals with history of gastrointestinal surgery including appendisectomy. 4. Individuals with any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator. 5.Individuals with concurrent chronic GI pathology (e.g. IBD, cystic fibrosis, short gut, celiac disease, frequent diarrhea without laxative). 6.Current pharmacological treatment related to constipation (e.g. prosecretory agents, antidepressants, antispasmodics, enterokinetic) 7. Individuals consuming dietary treatment (e.g. synbiotics, herbal extracts, fibers) or taking other therapies for treating constipation (e.g. cognitive behavior therapy, acupuncture, biofeedback, complementary and alternative Medicine) within 1 month prior to screening. 8. Use of antibiotics within 1 month prior to screening. 9. Use of products containing probiotics, prebiotics, postbiotics, within 1 month prior to screening. 10. Opioids-induced constipation. 11. Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT- antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs) within 1 month prior to screening. 12. Immuno-compromised participants. 13. Participants on immunosuppressive agents (e.g. heart or kidney transplant, chemotherapy agents, oral prednisolone) 14. History of cancer . 15. Individuals with known history of diabetes mellitus and are on medication for the same. 19. Psychiatric or behavioral disorders as judged by the Investigator 20. Individuals with known food allergy. 21. Individuals with eating disorders (e.g., anorexia, bulimia) 22. Pregnancy or lactation 23. Known allergic reactions to any components of the probiotics or placebo. 24. Individuals participating in other interventional study within 90 days prior to screening. 25. Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigators clinical judgment. 26. Current Smokers. 27. Individuals with more than 14 SBMs per week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs) per weekTimepoint: from baseline to the end of study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of Investigational product (IP) in comparison to baseline & placebo on stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit.Timepoint: from baseline to the end of study visit;To assess the effect of Investigational product (IP) in comparison Constipation symptoms by using Participant Assessment of Constipation Symptoms (PAC-SYM)Timepoint: from baseline to day 14, day 28, day 42, day 56, day 70 & day 84.;To assess the effect of Investigational product (IP) in comparison Quality of life by using Participant Assessment of Constipation QoL (PAC-QoL)Timepoint: from baseline to day 14, day 28, day 42, day 56, day 70 & day 84.;To assess the effect of Investigational product (IP) in comparison to Percentage responders defined as the number of participants with an increase by 1 or more frequencies of SBM with no sensation of incomplete evacuationTimepoint: from baseline to the end of intervention;To assess the effect of Investigational product (IP) in comparison Gut microbiome (alpha & beta diversity)Timepoint: from baseline to end of intervention;To assess the effect of Investigational product (IP) in comparison Difference in the usage of rescue medicationTimepoint: throughout the study duration as compared to placebo | — |
Countries
India
Contacts
Public ContactRushikesh Londhe
Vedic Lifesciences Pvt Ltd
Outcome results
None listed