Gastrointestinal-Functional Constipation Digestive System Gastrointestinal-Functional Constipation
Conditions
Interventions
Participants are randomly allocated to receive either one bottle (á 65ml) of fermented milk drink containing probiotic strain per day or placebo (acidified milk drink without any bacteria strains) for
Sponsors
Yakult Honsha Co. Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and non- pregnant females aged from 18 to 70 years 2. Body mass index (BMI) >18.0 and 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of CSBMs is measured using patient daily diary at week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of spontaneous bowel movements (SBMs) per person is measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 2. Number of participants with at least one CSBM improvement per week is measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 3. Number of SBMs per person is measured using daily diary at Week 12, and compared with the number at the baseline (Week -1) Absolute weekly SBM counts are measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 4. Number of patients with at least one SBM improvement per week is measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 5. Number of participants with at least three CSBMs per week is measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 6. Number of participants with at least three SBMs per week is measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 7. Number of persons having at least an increase of +1 CSBM for at least 6 weeks during the 12 weeks is measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 8. Stool form is measured using Bristol Stool Scale Form in the daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 9. Abdominal transit time is measured using radio opaque markers at Week zero (at start of the intervention) and Week 12 10. Number of participants who used laxatives once or more during the intervention is measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 11. Frequency of using laxatives is measured using daily diary at Week one, two, three, four, five, six, seven, eight, nine, ten, 11 and 12 Tertiary Endpoints: I. Change in constipation symptoms measured by PAC-SYM q | — |
Countries
Italy
Contacts
Public ContactCesare Mutti
Outcome results
None listed