Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children

NCT01564290

Acute Diarrhea Acute Gastroenteritis

COMPLETED PHASE4

Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

NCT03539913

Acute Gastroenteritis

COMPLETED PHASE4

Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

NCT02080130

Gastroenteritis

WITHDRAWN NA

Combined Lactobacilli (Reuteri LMG P-27481 and GG ATCC 53103) to Prevent Antibiotic Associated Symptoms in Children

NCT04836013

Diarrhea Caused by Drug Abdominal Pain

UNKNOWN NA

Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders

NCT02722993

Antibiotic-associated Diarrhea

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diarrhea Rotavirus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

This group will receive S. Boulardii Probiotic and Oral rehydration as needed

Group Type ACTIVE_COMPARATOR

GB (Florestor)

Intervention Type DRUG

S. Boulardii preparation of 1 gram twice daily for 5 days

2

This group will receive a mixed Probiotic preparation and oral rehydration as needed

Group Type ACTIVE_COMPARATOR

GRALB

Intervention Type DRUG

mixed probiotic preparation 1 gram twice daily for 5 days.

3

This group will receive a placebo, and oral rehydration as needed

Group Type PLACEBO_COMPARATOR

GC (placebo)

Intervention Type DRUG

Placebo 1 gram twice daily for 5 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GB (Florestor)

S. Boulardii preparation of 1 gram twice daily for 5 days

Intervention Type DRUG

GRALB

mixed probiotic preparation 1 gram twice daily for 5 days.

Intervention Type DRUG

GC (placebo)

Placebo 1 gram twice daily for 5 days.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Florestor, Bioflora Probiotik, mixed probiotic Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Positive stool sample for rotavirus test

Exclusion Criteria

* Severe malnourishment
* Severe dehydration
* Use of antibiotics, probiotics or nitazoxanide 2 weeks before admission
* Systemic infections
* Severe chronic disease
* Mixed enteric infections besides rotavirus

Minimum Eligible Age

1 Month

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No