Functional constipation
Conditions
Interventions
Positive Investigational Product:One sachet of positive investigational product per day: 40mg B. lactis HN019(10000000000 CFU)+10mg Silicon dioxide+1950mg Maltodextrin
Placebo:One sachet of placebo per day: 40mg Silicon dioxide+1990mg Maltodextrin
Sponsors
Shanghai 9th People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: At Visit 1 (Day-16): 1. Free-living females and males of age 18 to 70 years (limits included); 2. Body mass index between 18.5 (inclusive) and 30.0 (non-inclusive) kg/m2; 3. Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis): (1) Must meet 2 or more of the following criteria: 1) Straining during at least 25% of defecations; 2) Lumpy or hard stools in at least 25% of defecations; 3) Sensation of incomplete evacuation for at least 25% of defecations; 4) Sensation of anorectal obstruction/blockage for at least 25% of defecations; 5) Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor); 6) Fewer than three defecations per week; (2) Loose stools are rarely present without the use of laxatives; (3) Insufficient criteria for irritable bowel syndrome; 4. Self-reported bowel movement frequency up to 3 stools per week for at least the last 6 months; 5. Participants who agree to maintain their usual level of activity throughout the trial period; 6. Participants who agree to maintain their usual dietary habits and level of exercise etc; i.e. maintain their ususal life-style throughout the trial period; 7. Participants who agree not to consume probiotics (except for investigational products), prebiotics, synbiotics, fermented milk, and/or yogurt throughout the trial period; 8. Females of child-bearing potential who agree to use medically approved methods for birth control, those including condoms with spermicides, hormonal contraceptives (estrogen and/or progestin products; either oral, intrauterine or epidermal) or intrauterine device with copper. The contraceptive method should have been in place for at least 3 cycles before the beginning of the study, and should not be modified during the study. Postmenopausal women with or without hormone replacement therapy who have been applying the estrogenic or estogenic/progestin treatment for at least 3 months before the beginning of the study and who agree not to change the treatment during the study; 9. Ability of the participant (in the investigators opinion) to comprehend the full nature and purpose of the study including possible risks and side effects; 10. Consent to participate in the study and willing to comply with the protocol and study restrictions; 11. Ability of the participant to understand and fill out the 3-day diet questionnaire on themselves; 12. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to research involving the human person; 13. Participants who agree to be registered on the national file of the volunteers participating in biomedical research; At Visit 2 (Day-8): 14. Hematological, serum, and urine parameters within the normal range, or not clinically-relevant. Nonpregnant females, as indicated by negative pregnancy test; 15. 0 to 3 CSBMs over last 7 days, per daily diary log between Visit 1 and Visit 2 (Day -15 to Day -9); 16. 100% compliance with placebo consumption over last 7 days, per daily diary log between Visit 1 and Visit 2 (Day -15 to Day -9); 17.100% completion of daily diary over last 7 days, per daily diary log between Visit 1 and Visit 2 (Day -15 to Day -9); At Visit 3 (Day 0): 18. 0 to 3 CSBMs over last 7 days, per daily diary log between Visit 2 and Visit 3 (Day -7 to Day -1); 19. 100% comp
Exclusion criteria
Exclusion criteria: 1. Having hypersensitivity or history of allergy to one of the study products; 2. Suffering from a metabolic disorder (diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator; 3. Major gastrointestinal complication (e.g. Crohns disease, ulcer, IBS-Mixed, IBS-constipation, IBS-Diarrhea, Celiac disease); 4. Lactose-intolerants who consume non-lactose-free dairy products. e.g. regular milk, ice-cream. i.e. Lactose-intolerants who cannot manage their condition (those who manage their intolerance, i.e. lactose-intolerant participants who dont consume any product containing lactose, could be included in the study); 5. Prior abdominal surgery (e.g. gastric by-pass, gastrectomy, gastric band, visceral surgery) that, in the opinion of the investigator, may present a risk for the participant or confound study results; 6. Current pharmacological treatment related to constipation (e.g., prosecretory agents, antibiotics, antidepressants, antispasmodics, enterokinetics), dietary treatment of constipation (e.g. probiotics, prebiotics, synbiotics, herbal extracts, fibers), or other constipation treatments (e.g. cognitive behavior therapy, acupuncture, biofeedback) within 1 month before screening; 7. Laxative/suppository use (>=1/month) or laxative/suppository use within 48 hours of screening (rescue medications – e.g., laxatives, suppositories and rescue procedures- e.g., enemas, allowed for intolerable symptoms during study); 8. Daily consumption of probiotics, prebiotics, synbiotics, fermented milk, and/or yogurt containing probiotics within 2 weeks prior to screening; 9. Use of any drug or dietary supplement during at least 7 consecutive days known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminium, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs) within 1 month before screening; 10. Clinically significant underlying systemic illness that may preclude the participants ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness); 11. Systemic steroid use within 1 month before screening; 12. Eating disorder (e.g., anorexia, bulimia, etc.); 13. Having a lifestyle deemed incompatible with the study according to the investigator e.g., specific diet (vegetarian, vegan, hypocaloric), intense physical activity > 10 hours / week, etc.; 14. Self-declare history of alcohol abuse (for females: >3 drinks on any single day and >7 drinks per week; for males: >4 drinks on any single day and >14 drinks per week); According to U.S. standard drink, one serving of alcohol contains roughly 14 grams of pure alcohol, which is found in: (1) Regular beer (~5% alcohol): 350 ml (2) Malt liquor (~7% alcohol): 250 ml (3) Table wine (~12% alcohol): 150 ml (4) Fortified wine, such as sherry or port (~17% alcohol): 105 ml (5) Coridal liqueur, or aperitif (~25% alcohol): 75 ml (6) Brandy or cognac (~40% alcohol): 45 ml-a single jigger or shot (7) Distilled spirits (~40% alcohol): 45 ml 15. Self-declare use of illicit drugs; 16. Pregnant or lactating female, or pregnancy planned during study perio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete spontaneous bowel movements (CSBMs) per week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool consistency;Degree of straining;Abdominal pain severity;Bloating severity;Patient assessment of constipation symptoms;Patient assessment of constipation quality of life;Use of rescue medication; | — |
Countries
China
Contacts
Public ContactXiangjun Meng
Shanghai 9th People's Hospital
Outcome results
None listed