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

Inclusion Criteria:

1. Individuals agreed to the signed and dated informed consent form.

2. Male and female individuals of age between 18 to 60 years (both values included)

3. Individuals who meet Rome IV diagnostic criteria for functional constipation asindicated by the criteria fulfilled for the last 3 months with symptoms onset atleast 6 months prior to diagnosis: i. Must include two or more of the following criteria:

4. Fewer than three SBMs per week

5. Straining during more than ¼ (25%) of defecations

6. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) ofdefecations

7. Sensation of incomplete evacuation more than ¼ (25%) of defecations

8. Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations

9. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digitalevacuation, support of the pelvic floor) ii. Loose stools are rarely presentwithout the use of laxatives iii. Insufficient criteria for irritable bowelsyndrome

10. Individuals willing to comply with all study procedures and availability for theduration of the study as per the protocol.

11. Individuals willing to maintain the same dietary and physical activity practicesthroughout the study period.

12. Individuals with fewer than three CSBMs per week.

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, shortgut, 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 behaviortherapy, acupuncture, biofeedback, complementary and alternative Medicine) within 1month prior to screening.

8. Use of antibiotics within 1 month prior to screening.

9. Use of products containing probiotics, prebiotics, postbiotics, within 1 month priorto 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, calciumsupplements, calcium channel blockers, tricyclic antidepressants or NSAIDs) within 1month 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 thesame.

16. Individuals suffereing from Diabetic gastroparesis.

17. History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHgand/or diastolic blood pressure ≥ 90 mmHg.

18. Individuals with impaired thyroid function reported by TSH less than 0.4 mIU/L andmore than 5 mIU/L will be excluded. However, individuals on a stable dose ofmedication for past 6 months and within the aforementioned range, can be considered.

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 toscreening.

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.