CompletedPhase 2/3

Oral Rehydration Solution With Zinc and Prebiotics in Acute Diarrhea

Italy130 participantsStarted 2007-11

Plain-language summary

Hypotonic oral rehydration solutions (ORS) containing zinc and/or prebiotics have been proposed for the treatment of pediatric acute diarrhea but conclusive clinical data about their effect are scanty, especially for children living in developed countries. The investigators aim to evaluate the efficacy of a new hypotonic ORS containing zinc and prebiotics in children with acute diarrhea.

Who can participate

Age range

3 Months – 36 Months

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: * Children 3-36 months old seen in the pediatrician offices presenting acute diarrhea lasting less than 48 h are considered eligible for the study Exclusion Criteria: * Diarrhea lasting more than 48 h * Malnutrition as judged by a body weight/height ratio below the 5th percentile * Clinical signs of severe dehydration * Clinical signs of a coexisting severe acute systemic illness (meningitis, sepsis, pneumonia) * Immunodeficiency * Underlying severe chronic disease * Malnutrition * Cystic fibrosis * Food allergy or other chronic gastrointestinal diseases * Use of pre/probiotics in the previous 3 weeks * Use of antibiotics or any antidiarrheal medication in the previous 3 weeks.

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.

What they're measuring

The primary outcome of the study is the rate of resolution of diarrhea 72 h after starting oral rehydration therapy.

Timeframe: From November 2007 to January 2008

Trial details

NCT IDNCT01025583

SponsorFederico II University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-01

View on ClinicalTrials.gov More Diarrhea trials