Oral Rehydration Solution With Zinc and Prebiotics in Acute Diarrhea

NCT01025583 | Completed Phase 2 DMC

• 2 other identifiers: 184/0801§/2008
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhea

Keywords

acute gastroenteritis; intestinal infection; intestinal fluid secretion; intestinal microflora; treatment of childhood acute diarrhea

Outcome Measures

Primary Outcomes (1)

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

  From November 2007 to January 2008

Secondary Outcomes (1)

• Secondary outcome measures are the total amount of ORS intake in the first 24 h, the number of missed work days of the parent, the number of hospital admissions in each group, and the use of other medications.

  From November 2007 to January 2008

Study Arms (2)

group 1 (standard ORS)

ACTIVE COMPARATOR

Children with acute diarrhea receive standard hypotonic ORS.

Dietary Supplement: hypotonic oral rehydration solution

Group 2 (hypotonic super-ORS)

ACTIVE COMPARATOR

Children with acute diarrhea receive hypotonic super-ORS containing zinc and prebiotics.

Dietary Supplement: Hypotonic oral rehydration solution with Zn and prebiotics

Interventions

hypotonic oral rehydration solution DIETARY_SUPPLEMENT

30-50 ml/kg of ORS in 3-4 h for mild dehydration and with 50-100 ml/kg of ORS in 3-4 h for moderate dehydration, and to administer 10 ml/kg/die of ORS in a graduated glass or bottle for dehydration prevention until cessation of symptoms.

Also known as: REIDRAX

group 1 (standard ORS)

Hypotonic oral rehydration solution with Zn and prebiotics DIETARY_SUPPLEMENT

30-50 ml/kg of ORS in 3-4 h for mild dehydration and with 50-100 ml/kg of ORS in 3-4 h for moderate dehydration, and to administer 10 ml/kg/die of ORS in a graduated glass or bottle for dehydration prevention until cessation of symptoms.

Also known as: PREREID

Group 2 (hypotonic super-ORS)

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 3-36 months old seen in the pediatrician offices presenting acute diarrhea lasting less than 48 h are considered eligible for the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Pediatric Office

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Roberto Berni Canani, MD, PhD

  Department of Pediatrics, University Federico II of Naples Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 13, 2010

Record last verified: 2009-12

Locations

IT (1)