A Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation

Inclusion criteria

• Individuals agreed to the signed and dated informed consent form.
• Male and female individuals of age between 18 to 60 years (both values included)
• 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:

• Fewer than three SBMs per week
• Straining during more than ¼ (25%) of defecations
• Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
• Sensation of incomplete evacuation more than ¼ (25%) of defecations
• Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations
• Manual maneuvers to facilitate more than ¼ (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
• Individuals willing to comply with all study procedures and availability for the duration of the study as per the protocol.
• Individuals willing to maintain the same dietary and physical activity practices throughout the study period.
• Individuals with fewer than three CSBMs per week.

Exclusion criteria

• Individuals with well-known, organic cause of constipation (Polyps, hemorrhoids, etc.)
• Individuals with anorectal pathology
• Individuals with history of gastrointestinal surgery including appendisectomy.
• Individuals with any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator.
• Individuals with concurrent chronic GI pathology (e.g. IBD, cystic fibrosis, short gut, celiac disease, frequent diarrhea without laxative).
• Current pharmacological treatment related to constipation (e.g. prosecretory agents, antidepressants, antispasmodics, enterokinetic)
• 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.
• Use of antibiotics within 1 month prior to screening.
• Use of products containing probiotics, prebiotics, postbiotics, within 1 month prior to screening
• Opioids-induced constipation.
• 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.
• Immuno-compromised participants.
• Participants on immunosuppressive agents (e.g. heart or kidney transplant, chemotherapy agents, oral prednisolone)
• History of cancer .
• Individuals with known history of diabetes mellitus and are on medication for the same.
• Individuals suffereing from Diabetic gastroparesis.
• History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
• Individuals with impaired thyroid function reported by TSH less than 0.4 mIU/L and more than 5 mIU/L will be excluded. However, individuals on a stable dose of medication for past 6 months and within the aforementioned range, can be considered.
• Psychiatric or behavioral disorders as judged by the Investigator
• Individuals with known food allergy.
• Individuals with eating disorders (e.g., anorexia, bulimia)
• Pregnancy or lactation
• Known allergic reactions to any components of the probiotics or placebo.
• Individuals participating in other interventional study within 90 days prior to screening.
• Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigators clinical judgment.
• Current Smokers.
• Individuals with more than 14 SBMs per week.