Last updated: April 15, 2024
Sponsor: Lallemand Health Solutions
Overall Status: Completed
Phase
2/3
Condition
Heartburn
Colic
Bowel Dysfunction
Treatment
Placebo
Lacidofil
Clinical Study ID
NCT04473079
I-020
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Thai patients consulting for dyspeptic symptoms.
- Aged between 18 and 65 years.
- Diagnosed for H. pylori infection using RUT and 13C-UBT.
- H. pylori treatment naïve.
- Able to provide informed consent.
- Willing to maintain their usual physical activity regime and diet, as well asdiscontinuing the consumption probiotic-containing and fermented foods.
Exclusion
Exclusion Criteria:
- Upper gastrointestinal bleeding.
- Presence of duodenal or gastric ulcers, MALT lymphoma, gastric resection, gastricmalignancy as per endoscopy (visual assessment).
- Current intake of antibiotics, such as amoxicillin, clarithromycin, metronidazole orfluoroquinolone.
- Use of probiotics in the past month, and unwilling to undergo a 2-week washout periodbefore the study.
- Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasionaluse) or 3 weeks (for chronic use) of inclusion.
- Contraindication for gastric biopsy (e.g., coagulopathy).
- Any history of allergy for penicillin, levofloxacin, clarithromycin or rabeprazole.
- Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuthwithin 2 weeks of trial initiation.
- Being pregnant or breastfeeding.
- Having severe underlying disease including end-stage renal disease requiringhemodialysis or peritoneal dialysis (GFR < 15), cirrhosis with Child-Pughclassification grade C, immuno-compromised host with AIDS, malignancy and/orcerebrovascular or cardiovascular disease.
- Taking anticoagulants (e.g., warfarin) or anti-platelet agents (e.g., clopidogrel)
- Previous gastric surgery.
- Having underlying heart disease, including congenital long QT syndrome.
- Unwilling to stop taking over-the-counter, natural or herbal medicines for dyspepticor gastrointestinal symptoms (e.g., antidiarrheal, anti-emetics, antacids) during theintervention period (6 weeks).
- Milk and soy allergy.
- Lactose intolerance.
Study Design
Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
October 16, 2020
Estimated Completion Date:
June 17, 2022
Study Description
Connect with a study center
Thammasat University Hospital
Khlong Luang, Pathumthani 12120
ThailandSite Not Available
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