Irritable bowel syndrome-diarrhea
Conditions
Interventions
Lactobacillus acidophilus CCFM1200 group:Taking Lactobacillus acidophilus CCFM1200
Bifidobacterium breve CCFM1300 group:Taking Bifidobacterium breve CCFM1300
Sponsors
WuXi NO 2 Peoples Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria (1) Fulfilled the diagnosis of diarrhoeal irritable bowel syndrome according to the above diagnostic criteria (2) Males and females (18-70 years old); (3) Organic gastrointestinal pathology is excluded, and diarrhoeal irritable bowel syndrome can be diagnosed when the following Rome IV criteria are met: Recurrent episodes of abdominal pain, with episodes averaging at least 1 day per week over the past 3 months, associated with at least 2 of the following: A. associated with defecation; B. accompanied by a change in the frequency of defecation; C. accompanied by a change in the character or appearance of the faeces. (4) Diarrhoea is considered to be diarrhoea according to the Bristol Stool Profile Scale, types 6 and 7. (5) Have not used any medication that affects gastrointestinal motility in the past week; (6) Good compliance with clinical trial requirements; (7) Subjects or guardians have signed informed consent; (8) Blood routine, urine routine, stool routine + occult blood, liver and renal function tests are in the normal range before treatment, and enteroscopy excludes organic diseases. (9) The patient has filled out a written informed consent form, a basic information questionnaire, a dietary structure and living conditions questionnaire, and has committed to co-operate with the study throughout the experimental period. (10) IBS-SSS scale score of ‘mild’, ‘moderate’ or ‘severe’
Exclusion criteria
Exclusion criteria: Those with the following conditions were not enrolled: (1) Severe diarrhoea or those with more severe and complex diarrhoeal symptoms such as mucoid or bloody stools, stools with red or white blood cells present, those requiring antibiotic treatment, and the presence of ulcers are excluded from the study; (2) Subjects with adverse reactions or serious adverse reactions, pregnancy, lactation, disease emergencies, concomitant therapy and study protocol violations will be considered for withdrawal from the trial; (3) Organic gastrointestinal diseases (inflammatory bowel disease, celiac disease, gastrointestinal infections and gastrointestinal tumours, etc.); (4) Organic diseases (hepatic, renal and cardiac insufficiency, diabetes mellitus and tumours, etc.); (5) Blood, urine and faecal biochemical indicators more than 1.5 times the normal value; (6) Those who are unable to comply with observation due to long-term alcoholism, drug abuse or mental factors; (7) Long-term abuse of antidiarrhoeal drugs or systemic corticosteroids; (8) Patients who refused to sign the informed consent form, or estimated poor compliance and poor likelihood of follow-up; (9) Use of antibiotics, probiotics (yoghurt, drinks, etc.), laxatives, and other medications that may interfere with bowel movements within 4 weeks prior to study entry; (10) Those using antibiotics for a long period of time; (11) Allergy or intolerance to the ingredients of the experimental probiotic products. (12) Other cases that did not meet the inclusion criteria.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Plasma serotonin;Plasma acetylcholine ACh;Plasma substance P;Serum tumor necrosis factor-a;Serum interferon-?;Serum interleukin-6;Serum interleukin-8;Serum interleukin-10;Serum gastrin;Serum ghrelin;Serum vasoactive intestinal peptide;Fecal metagenome;Fecal short-chain fatty acids;Fecal abundance of Lactobacillus ;Fecal abundance of Bifidobacterium; | — |
Primary
| Measure | Time frame |
|---|---|
| IBS-SSS questionnaire;IBS-QOL questionnaire;VSI questionnaire; | — |
Countries
China
Contacts
Public ContactGaojue Wu
Wuxi No 2 Peoples Hospital
Outcome results
None listed