Human Milk Oligosaccharides and Childhood Diarrhoea

NCT02896465 | Completed

• 1 other identifier: 13.26.INF
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diarrhea

Keywords

Children; Diarrhea; Human milk oligosaccharides

Outcome Measures

Primary Outcomes (1)

• Improvement (change) of clinical symptoms of diarrhea

  Passage of the last abnormal stool prior to formed/ soft stools during two consecutive 8-hour periods.

  Day1, Day2, Day3, Day4, Day5, Day6, Day7

Secondary Outcomes (8)

• Stools output

  Day1, Day2, Day3, Day4, Day5, Day6, Day7

• Weight gain

  Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day14

• Adverse events

  Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day14

• Daily stool frequency

  Day1, Day2, Day3, Day4, Day5, Day6, Day7

• The number of vomiting

  Day1, Day2, Day3, Day4, Day5, Day6, Day7

Study Arms (3)

ORS+ZINC

ACTIVE COMPARATOR

Oral rehydration solution + Zinc

Other: Oral rehydration solution; Other: Zinc

ORS+ZINC+HMO

EXPERIMENTAL

Oral rehydration solution + Zinc + Human milk oligosaccharides

Other: Oral rehydration solution; Other: Zinc; Other: Human milk oligosaccharides

ORS+ZINC+Breastfeeding

PLACEBO COMPARATOR

Oral rehydration solution + Zinc + Breastfeeding

Other: Oral rehydration solution; Other: Zinc; Other: Breastfeeding

Interventions

Oral rehydration solution OTHER

Also known as: ORS

ORS+ZINC; ORS+ZINC+Breastfeeding; ORS+ZINC+HMO

Zinc OTHER

ORS+ZINC; ORS+ZINC+Breastfeeding; ORS+ZINC+HMO

Human milk oligosaccharides OTHER

Also known as: HMO

ORS+ZINC+HMO

Breastfeeding OTHER

ORS+ZINC+Breastfeeding

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Both male and female children between the ages of 6 months to 2 years.
• Acute diarrhoea (\<48 hours) without interfering co-morbidities, e.g. acute respiratory tract infection, sepsis, gross electrolyte imbalances etc.
• 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.
• Written informed consent must be obtained prior to admission to this study.
• The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.

You may not qualify if:

• 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)
• Symptom duration \> 48 hours at screening.
• Vomiting severity that is likely to make administration and retention of test product impossible.
• 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).
• Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening.
• Children with any food allergy.
• Breast-fed children, (Group III - Reference group)
• Exclusive Breastfed children Either sex: Male and female
• Age 6-12 month
• Acute diarrhoea (\<48 hours) without interfering co-morbidities, e.g. acute respiratory tract infection, sepsis, gross electrolyte imbalances etc.
• Written informed consent must be obtained prior to admission to this study.
• The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

International Center for Diarrheal Disease Research

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Diarrhea

Interventions

World Health Organization oral rehydration solution; ORALIT; Zinc; Health Maintenance Organizations; Lactation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: September 12, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)