Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and… (NCT02900196) | Clinical Trial Compass
TerminatedNot Applicable
Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders
Stopped: Sponsor decision
Germany136 participantsStarted 2016-09-16
Plain-language summary
The purpose of this clinical study is to evaluate the effect of a four-week consumption of a fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori eradication.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects who have read and signed the Study Informed Consent Form
* Subjects positive for Helicobacter pylori infection and symptomatic due to Helicobacter pylori infection
* Subjects with an indication, as stated by a Gastroenterologist, for the eradication of Helicobacter pylori
Exclusion Criteria:
* Female subjects with a positive pregnancy test (based on serum test), or planning to become pregnant during the study or breast-feeding women
* Subjects enrolled in another interventional clinical study in the last 4 weeks or in an exclusion period following participation in another clinical trial
* Subject who have a history of alcohol abuse
* Subjects having diarrhea within the preceding 4-weeks
* Subjects with severe life-threatening illness, severe evolutive or chronic pathology
* Immune-suppressed subjects
* Subjects with benign peptic ulcer or pre-malignant or malignant lesion
* Subjects presenting with an infection of the gastrointestinal tract
* Subjects with any past severe gastro-intestinal or metabolic pathology
* Subjects with history of Helicobacter pylori eradication therapy
* Subjects with history of cardiac or renal clinically significant disease
* Subjects that have had any surgery or intervention requiring general anesthesia in the last 4 weeks, or that have any planned
* Subjects with allergy or hypersensitivity against the medication for the eradication of Helicobacter pylori
* Subjects taking treatments likely to interfere with the …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.