Human Milk Oligosaccharides and Childhood Diarrhoea

NCT ID: NCT02896465

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 435 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-02-28

Brief Summary

Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients hospitalized with acute diarrhoea.

Detailed Description

The trial is single site, double blind, randomized of HMO addition (1.5 g /day) to standard of care in paediatric diarrhoea patients. HMO application and follow-up of the children at home will be done for 2 weeks. Control patients receive only the standard of care (ORS plus zinc). A breastfed group of diarrhoea patients will serve as reference group.

The total sample size is 495 patients. Patients will be females and males aged 6 months to 2 years old with acute diarrhoea.

Conditions

Acute Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

ORS+ZINC

Oral rehydration solution + Zinc

Group Type: ACTIVE_COMPARATOR

Oral rehydration solution

Intervention Type: OTHER

Zinc

Intervention Type: OTHER

ORS+ZINC+HMO

Oral rehydration solution + Zinc + Human milk oligosaccharides

Group Type: EXPERIMENTAL

Oral rehydration solution

Intervention Type: OTHER

Zinc

Intervention Type: OTHER

Human milk oligosaccharides

Intervention Type: OTHER

ORS+ZINC+Breastfeeding

Oral rehydration solution + Zinc + Breastfeeding

Group Type: PLACEBO_COMPARATOR

Oral rehydration solution

Intervention Type: OTHER

Zinc

Intervention Type: OTHER

Breastfeeding

Intervention Type: OTHER

Interventions

Oral rehydration solution

Intervention Type: OTHER

Zinc

Intervention Type: OTHER

Human milk oligosaccharides

Intervention Type: OTHER

Breastfeeding

Intervention Type: OTHER

Other Intervention Names

ORS; HMO

Eligibility Criteria

Inclusion Criteria

1. Both male and female children between the ages of 6 months to 2 years.

2. Acute diarrhoea (<48 hours) without interfering co-morbidities, e.g. acute respiratory tract infection, sepsis, gross electrolyte imbalances etc.

3. Guardian is willing to have the child admitted to the hospital as an inpatient until resolution of diarrhea and to return to the clinic with the child on Day 14 after admission for a final evaluation.

4. Written informed consent must be obtained prior to admission to this study.

5. The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.

Exclusion Criteria

1. Children of either sex who are fully or partially breast-fed until one week before enrolment (since breastfed children receive naturally HMO, their inclusion into the ORS/zinc or HMO/ORS/zinc arms would critically interfere with the study question; depending on children's age 30 to 50 % of mothers would do so at icddr,b). However, an unblinded reference group will be constituted by age-matched children who are breastfed at the moment of hospitalization for acute diarrhea and where the mothers want to continue breastfeeding on the study ward (so breastfeeding is only an exclusion for the randomized groups).

2. Suspected or confirmed cholera as detected by a positive DF examination in stool collected on admission. (The large volume and quick evacuation of stool could interfere with product presence in the gut)

3. Symptom duration > 48 hours at screening.

4. Vomiting severity that is likely to make administration and retention of test product impossible.

5. Severe malnutrition defined (using z-scores) as: severe stunting (SS; height-for-age z-score < -3.00); severe underweight (SU; weight-for-age z-score < -3.00), and severe wasting (SW; weight-for-height z-score < -3.00), using the World Health Organization reference value. Moderate malnutrition was defined as follows: moderate stunting (height-for-age z-score -3.00 to < -2.00); moderate underweight (weight-for-age z-score -3.00 to < -2.00); and moderate wasting (weight-for-height z-score -3.00 to < -2.00). We considered children as well-nourished if their z-scores for weight-for-age, height-for-age and weight-for-height z-score were form -2.00 to +1.00.

Children with moderate malnutrition will be enrolled since they develop with higher frequency PD).

6. Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening.

7. Children with any food allergy.

Breast-fed children, (Group III - Reference group)

1. Exclusive Breastfed children Either sex: Male and female

2. Age 6-12 month

3. Acute diarrhoea (<48 hours) without interfering co-morbidities, e.g. acute respiratory tract infection, sepsis, gross electrolyte imbalances etc.

4. Written informed consent must be obtained prior to admission to this study.

5. The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

International Center for Diarrheal Disease Research

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

13.26.INF

Identifier Type: -

Identifier Source: org_study_id