Evaluating the effects of Lactobacillus acidophilus (Johnsonii) La1, as a postbiotic supplementation, on diarrhoea, associated gastrointestinal symptoms and quality of life in patients with antibiotic associated diarrhoe (AAD). Allergic and dietetic gastroenteritis and colitis
Conditions
Interventions
Intervention 1: Intervention group: All participants will receive a capsule of postbiotic twice daily for four days, scheduled 2 to 3 hours apart from antibiotic intake, in accordance with their medic
Sponsors
Islamic Azad University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 to 75 years Currently receiving systemic antibiotic treatment (the type of antibiotic may vary) Confirmed antibiotic-associated diarrhoea At least three episodes of loose or watery stools per day Agreement to follow the study medication regimen and to refrain from using other postbiotic products Signed informed consent after being informed about the potential benefits and risks of the study
Exclusion criteria
Exclusion criteria: Patients with abnormal colonoscopy findings Those with known tumors History of colorectal cancer or chronic pancreatitis Individuals with other chronic diseases that may affect gastrointestinal function Presence of blood in the stool or severe dehydration Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period History of chronic gastrointestinal disorders such as Crohn’s disease or ulcerative colitis Lactose intolerance Electrolyte imbalances Immunodeficiency conditions (such as HIV/AIDS, organ transplant recipients) Patients undergoing radiotherapy or chemotherapy History of substance abuse, including alcohol or drug abuse Patients with chronic diarrhea not associated with antibiotic use History of gastrointestinal surgery or significant gastrointestinal conditions that may interfere with the study Enteral nutrition exceeding 350 mOsm/kg Use of other bioactive products such as probiotics, prebiotics, or other related products Known allergic reaction to the investigational drug or its related products Unwillingness to continue participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily frequency of bowel movements. Timepoint: Daily. Method of measurement: A validated questionnaire based on WHO criteria.;Stool consistency. Timepoint: Daily. Method of measurement: A validated questionnaire based on Bristol Scale Score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Associated gastrointestinal symptoms. Timepoint: Daily. Method of measurement: A validated questionnaire based on Gastrointestinal Symptom Rating Scale.;Quality of life. Timepoint: At the beginning and end of the intervention. Method of measurement: SF-36 quality of life questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFateme Ansari
Islamic Azad University
Outcome results
None listed