Clinical trial with fermented milk drink on functional constipatio

Completed

• Conditions: Gastrointestinal-Functional Constipation; Digestive System

• Registration Number: ISRCTN78807934
• Lead Sponsor: Yakult Honsha Co. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-29
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Males and non- pregnant females aged from 18 to 70 years
2. Body mass index (BMI) >18.0 and <30 kg/m2
3. Diagnosed as a subgroup of functional constipation, fulfilling Rome III criteria for functional constipation and have a defecation frequency of <3 SBMs per week with a diagnosis of >3 months and with symptom onset at least 6 months before diagnosis at the screening visit V0. Subjects are required to have BM frequency <3 CSBMs per week at the baseline visit V1 during the 2 weeks before randomization.
4. Agree to avoid using any laxative during the baseline period and the study period except in the case the investigator allows him/her to have rescue medication
5. No use of laxatives within 15 days before baseline
6. No consumption of forbidden foods in the previous 30 days before V0 (according to the list of forbidden foods A)
7. Ability of the participant (in the investigator’s opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
8. Consent to the study and willing to comply with study product and method
9. Agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state (according to the forbidden food list) and not to make any major lifestyle changes (e.g. changing their exercise pattern) during the trial

Exclusion Criteria

1. Neurological, pharmacological or organic cause for constipation
2. Subjects with 3 or more CSBMs at week -2 or at week -1
3. Habitual users of laxatives, since 3 months before enrolment
4. Major neurological disease or injury (e.g. Multiple sclerosis, Spinal Cord Injury - SCI)
5. Major gastrointestinal complication (e.g. Crohn’s disease, colitis, celiac disease, lactose intolerance and allergy to cow-milk proteins).
6. Febrile diverticulitis within 1 year before enrolment
7. Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, except appendectomy, haemorrhoidectomy and cholecystectomy
8. Any subject who on first assessment has symptoms requiring urgent medical assessment or treatment (e.g. rectal bleeding which requires endoscopy)
9. Any subject that present abdominal pain as a predominant symptom
10. Any subject that need manual maneuvers (digital insertion into the rectum, perianal pressure or vaginal splinting) to evacuate stools.
11. Any subject presenting a condition that constitutes a contraindication to probiotics (e.g. immunosuppressed, active current sepsis, untreated carcinoma)
12. Any subject presenting any alarm symptoms or situation requiring as a recommended test a colonoscopy (according to WGO Global Guideline Constipation 8, World Gastroenterology Organization, 2010)
13. Pregnancy and expected pregnancy within coming 18 weeks
14. Antibiotic use in the previous 12 weeks
15. Use of drugs or alimentary supplements known to cause constipation
16. Subjects who do not have the capacity to consent
17. Anticipated major dietary or exercise changes during the study period
18. Subjects known to exceed in the consumption of the following foods, for example due to dietary reasons: yogurt, cheese, soy/rice or other products only containing L. bulgaricus and S. thermophilus as viable bacteria; fermented milks, cheese, soy/rice products and other dairy/non-dairy products containing unknown viable bacteria or different from probiotic bacteria; foods naturally rich in prebiotics
19. Known allergies to any substance in the study product
20. Eating disorder (anorexia, bulimia, binge eating disorder, obesity)
21. History of alcohol, drug or medication abuse
22. Participation in another study with any investigational product within 3 months before enrolment
23. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified