Safety and Efficacy of Probiotics in Bangladeshi Infants

Healthy Clinical Trial

Official title:

Safety and Efficacy of Probiotics in Bangladeshi Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899378
• Other study ID #: SPO109949
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2013
• Last updated: October 13, 2016
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardBangladesh: Ethical Review Committee and Data Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 3 Months

Eligibility

Inclusion Criteria:

• Healthy infants.

• Infants 1 -3 months of age at the beginning of the study.

• Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.

• Parents and child are planning to remain in Dhaka for the next four months.

Exclusion Criteria:

• Infants with known birth defects.

• Infants who have been hospitalized.

• Infants who have an acute infection or illness at the time of enrolment.

• Infants who are currently taking antibiotics

• Infants <1 month of age or >3 months of age.

• Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).

• Infants who are already receiving a probiotic product or treatment.

• A diagnosis or suspicion of immunodeficiency disorder.

• A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.

• Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Lactobacillus reuteri DSM 17938
10^8 CFU
• Bifidobacterium longum infantis
10^9 CFU

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	International Centre for Diarrhoeal Disease Research, Bangladesh, Thrasher Research Fund

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of probiotic in the stool	presence of absence of each probiotic in the stool	weeks 0-12	No
Primary	Adverse events	Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms	duration of study - through study completion	Yes
Secondary	quantity of probiotic in the stool	amount of each probiotic present in the stool	weeks 0-12	No
Secondary	composition of microbiota	microbial community composition	weeks 0-12	No
Secondary	clinical effects	fever, diarrhea, wheezing, rash, stool frequency, feeding frequency	daily for 7 days after first probiotic administration, then weeks 2-12	Yes
Secondary	gut function	lactulose/mannitol ratio	months 0, 1, 2, 3	No
Secondary	gut inflammation	fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth	months 0,1,2,3	No
Secondary	gut inflammation/translocation	IL22, CD-14, total IgG and c-reactive protein	months 0, 1, 2, 3	No
Secondary	growth	weight, length, head circumference	month 0, 1, 2, 3	No
Secondary	breastfeeding rates		month 0, 1, 2, 3	No