ISRCTN61965252
Completed
Phase 4
A randomized, double-blind, controlled trial to evaluate the efficacy and safety of a combination of xyloglucan and gelose associated to oral rehydration salts for the treatment of acute diarrhea in children (iDEA STUDY)
OVENTURE S.L.0 sites100 target enrollmentApril 24, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Acute diarrhea
- Sponsor
- OVENTURE S.L.
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2021 results in https://pubmed.ncbi.nlm.nih.gov/33028102/ (added 12/05/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Acute gastroenteritis defined as a change in stool consistency according to the Bristol Stool Form (BSF) scale and/or an increase in the frequency of evacuations (typically \=3 in 24 h) lasting more than 1 day and no longer than 3 days
- •2\. Age group of children between \= 3 months and \= 14 years
- •3\. A caregiver must provide written informed consent
Exclusion Criteria
- •1\. Use of antibiotics, gelatine tannate, diosmectite, other probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment
- •2\. Exclusive breast feeding
- •3\. Chronic diarrheal gastrointestinal disease (eg. inflammatory bowel diseases, cystic fibrosis, coeliac disease, food allergy)
- •4\. Immunodeficiencies
- •5\. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)
- •6\. If needed, discontinuation or modification of the treatment may be considered at the discretion of the physician
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
utriBrain: A controlled study to investigate the effect of a food product on brain development in very early born infantsISRCTN96620855utricia Research88
Completed
Phase 2
Innovations in the management of musculoskeletal pain with alpha-lipoic acidISRCTN58259979Physicians Services Incorporated Foundation27
Completed
Phase 1
Investigating the effects of repeated once-daily administration of the non-hormonal Neurokinin 1,3 receptor antagonist NT-814 on sex hormone levels in healthy womeReproductive hormone levels in women with hormone-driven disordersNutritional, Metabolic, EndocrineISRCTN11913515KaNDy Therapeutics33
Completed
Not Applicable
An observation of the peer-assisted learning method in the clinical teaching of vertigo/dizziness-related diseases for standardized residency training students in ChinaClinical teaching of vertigo/dizziness-related diseases for SRT students in ChinaNot ApplicableISRCTN53773239Army Medical University198
Completed
Not Applicable
The effect of age and timing of protein consumption on energy intake and appetite.Healthy ageing, nutrition, appetite, energy intakeNutritional, Metabolic, EndocrineISRCTN99945020niversity of Sheffield24