Irritable bowel syndrome
Conditions
Interventions
Placebo group:Soy protein and maltodextrin
Oligosaccharide group:Soy protein and oligosaccharides
Bifidobacterium bifidum F35 group:Bifidobacterium bifidum F35
Sponsors
Jiangnan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women (=18-70 years) patients with diarrhea-predominant irritable bowel syndrome (IBS-D patients). 2. BMI between 19–35 kg/m2 (both inclusive). 3. In line with the IBS-D diagnostic criteria, was diagnosed as IBS-D. 4. Patients signed the informed consent form (Schedule 1), completed the basic situation questionnaire (Schedule 2), diet structure and living conditions questionnaire (Schedule 3), IBS related scales (IBS-SSS and IBS-QOL, Schedule 4) and promised to cooperate with the study throughout the experiment.
Exclusion criteria
Exclusion criteria: 1. Subjects who have chronic diseases, infectious diseases or serious disease diseases; 2. Subjects who have respiratory and/or gastrointestinal infections. Subjects who have other respiratory and / or gastrointestinal diseases; 3. Subjects who have had a major abdominal surgery, especially gastrointestinal surgery; 4. Any physical abnormality or medical condition that might have an effect on GI discomfort or on the evaluation of effects of the consumption of the investigational products; 5. Gastrointestinal cancer or IBD family history; 6. Within 2 weeks consumption of gastrointestinal disorders related drugs, such as anti-spasmodic drugs, laxatives, anti-diarrhea drugs; 7. Current or recent (within 1 month) or long term consumption of probiotics, dietary supplements, or herbs; 8. Current or recent (within 1 month) or long term consumption of yogurt, probiotic drinks; 9. Current or recent (within 1 month) or long term consumption of antibiotics; 10. Hypersensitivity to any of the ingredients of the study products or lactose intolerance; 1) Change of dietary habits within 1 month prior to the screening visit, e.g. start of fibre-enriched diet; 2) For women: Pregnancy, lactation or wish to become pregnant; 3) Subjects who have a history of convulsions or mental illness; 4) Currently or recently (within 1 month) is participating in other clinical studies; 5) Not willing or able to provide written informed consent for participation in the study after being informed by the study personnel about the aim, course and possible risks of the study; 6) Subjects who are unable to comply with the requirements of the study or who in the opinion of the study personnel should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal Metagenome;IBS Symptom Severity Scale;IBS Quality of Life;IBS Adequate Relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal short chain fatty acid;C-reactive protein;Interferon;Tumor necrosis factor-a;Interleukin-6;Interleukin-1ß;Interleukin-2;Interleukin-12;Interleukin-10;Interleukin-17;Interleukin-23;Histamine;Tryptase;Myeloperoxidase;Blood routine examination;Blood biochemical examination;serotonin;Interleukin-22; | — |
Countries
China
Contacts
Public ContactWenwei Lu
Jiangnan University
Outcome results
None listed