Human Milk Oligosaccharides and Childhood Diarrhoea

Acute Diarrhea Clinical Trial

Official title:

Treatment of Acute Childhood Diarrhoea With Human Milk Oligosaccharides and Impact on Gut Micro Biota Dysbiosis and Nutritional Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896465
• Other study ID #: 13.26.INF
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: February 2019

Study information

• Verified date: July 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 2 Years

Eligibility

Inclusion Criteria: Non breast-fed children (group I and group II):

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: Non breast-fed children (group I and group II):

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.

Related Conditions & MeSH terms

• Acute Diarrhea
• Diarrhea

Intervention

Other:
• Oral rehydration solution

• Zinc

• Human milk oligosaccharides

• Breastfeeding

Locations

Country	Name	City	State
Bangladesh	International Center for Diarrheal Disease Research	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stools output	Stools output, expressed as g/kg of body weight (cumulative output)	Day1, Day2, Day3, Day4, Day5, Day6, Day7
Secondary	Weight gain		Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day14
Secondary	Adverse events		Day1, Day2, Day3, Day4, Day5, Day6, Day7, Day14
Secondary	Daily stool frequency		Day1, Day2, Day3, Day4, Day5, Day6, Day7
Secondary	The number of vomiting		Day1, Day2, Day3, Day4, Day5, Day6, Day7
Secondary	The duration of vomiting		Day1, Day2, Day3, Day4, Day5, Day6, Day7
Secondary	Change in Z-score		Day1, Day14
Secondary	The amount of ORS to correct dehydration expressed as ml ORS /kg body weight, daily and cumulative input		Day1, Day2, Day3, Day4, Day5, Day6, Day7