Evaluating the effect of administration of Lactocare® probiotic on gasterointestinal symptoms and Anti-Ttg antibody in patients with celiac disease: Randomized controlled Clinical trial
Phase 3
Recruiting
- Conditions
- celiac disease.Celiac diseaseK90.0
- Registration Number
- IRCT20080921001264N12
- Lead Sponsor
- Gorgan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
Confirmation of celiac disease with small intestine biopsy
Measurement of antibody titer against tissue transglutaminase (Anti TTg)
Age above 18 years
Exclusion Criteria
Any recent infections
Concomitant inflammatory bowel disease (IBD)
Immune deficiency (acquired or non-acquired)
Taking drugs that affect the immune system (immune suppressors and stimulants)
Recent GI surgery
Taking NSAID painkillers or antibiotics in the last 6 weeks
Having cancer or being HIV positive
Cardiovascular diseases, glands, kidney, liver, neurological or mental malignancy
Pregnancy and breastfeeding
Alcohol and drug addiction
Participation in another similar study within the last 6 months
unwillingness to take probiotics
patient being out of reach
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The severity and extent of disease symptoms. Timepoint: The beginning of the study and 6 weeks after the start of the study. Method of measurement: CSI ( celiac symptom index ) questionnaire.;Tissue transglutaminase antibody titer (Anti-Ttg). Timepoint: The beginning of the study and 6 weeks after the start of the study. Method of measurement: titer Anti-TTG.
- Secondary Outcome Measures
Name Time Method