Probiotics for Infectious Diarrhea in Children in South India

NCT ID: NCT01130792

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-07-31

Brief Summary

The overall goal of this study is to investigate whether the modulatory effects of probiotics, which are used as food supplements (Lactobacillus GG marketed as Culturelle or yoghurt) in the gastrointestinal tract promote restoration of intestinal function and enhance the specific immune response in children with cryptosporidial or rotaviral infections in South India. Rotavirus and Cryptosporidium spp. are the most important viral and parasitic causes of gastroenteritis in children in south India. Both infections can lead to severe dehydrating gastroenteritis in young children and have no specific treatment. Repeated episodes of diarrhea can result in long term deleterious effects on nutritional status, possibly due to intestinal damage. Most episodes of infectious gastroenteritis resolve without specific therapy, the mainstay of treatment being rehydration. However, oral rehydration remains under-utilized, in part due to the lack of effect on frequency of bowel movements and duration of illness. Due to the interest in simple, safe and effective measures to ameliorate the long-term effects of diarrheal illness, there is a growing appreciation for the potential of certain microorganisms to offer direct benefits to the health of a host. Probiotics are known to beneficially modulate several host functions, the most important of which are immune responses and intestinal barrier integrity. The investigators propose to build on the investigators previous collaborative efforts to conduct pilot studies to provide a mechanistic understanding of the effect of probiotic supplementation in children with rotaviral and cryptosporidial diarrhea.

Based on the established efficacy of LGG for the treatment of a variety of diarrheal diseases and the documented modulation of immune responses and strengthening of intestinal epithelial barrier function by probiotics, the investigators propose to conduct a Phase I/II double-blind randomized placebo controlled clinical trial to assess the preliminary efficacy and safety of LGG vs. placebo in the resolution of symptoms and restoration of intestinal function in children with either rotaviral or cryptosporidial diarrhea and no other detected enteric infection. Promising results in this Phase I/II study will provide preliminary data to power a future randomized trial on these critical outcomes following rotaviral or cryptosporidial infection.

Conditions

Infectious Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Lactobacillus GG

LGG once daily for 4 weeks

Group Type: EXPERIMENTAL

Lactobacillus GG

Intervention Type: DIETARY_SUPPLEMENT

10 Billion Organisms Given Mixed In Milk As Food Supplement Once Daily For Four Weeks

Inulin

Group Type: PLACEBO_COMPARATOR

Inulin

Intervention Type: DIETARY_SUPPLEMENT

Identical appearing capsules containing a powder resembling the LGG to be given as for intervention

Interventions

Lactobacillus GG

10 Billion Organisms Given Mixed In Milk As Food Supplement Once Daily For Four Weeks

Intervention Type: DIETARY_SUPPLEMENT

Inulin

Identical appearing capsules containing a powder resembling the LGG to be given as for intervention

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Male and female children aged 6 months to 5 years
• Diagnosis of rotaviral or cryptosporidial gastroenteritis (Rotavirus or
• Cryptosporidium EIA positive and three or more watery stools within a 24-hour period)
• No other enteric pathogen isolated from the stool at the time of enrollment
• Able to take the contents of study capsules mixed into food or milk
• No need for antibiotics for current illness
• No use of LGG/other probiotics within 30 days (yogurt consumption is not an exclusion criterion)
• HIV negative
• No severe malnutrition (WAZ score < 3SD below the median)
• No evidence of active bowel leak, acute abdomen or colitis
• No history of allergy
• Parent/guardian willing to report on compliance and side effects during the study period
• Families willing to provide informed consent, participate in study and have study personnel visit their home.

Exclusion Criteria

• Other enteric pathogens isolated from the stool at the time of enrollment
• Not willing or able to take the contents of study capsules mixed into food or milk
• Need for antibiotics for current illness
• HIV positive
• Severe malnutrition (WAZ score < 3SD below the median)
• Presence of active bowel leak, acute abdomen or colitis
• History of allergy
• Parent/guardian not willing to report on compliance and side effects during the study period
• Families not willing to provide informed consent, participate in study or have study personnel visit their home.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: collaborator

Christian Medical College, Vellore, India

OTHER

Sponsor Role: lead

Responsible Party

Gagandeep Kang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gagandeep Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Honorine D Ward, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Christian Medical College

Vellore, Tamil Nadu, India

Countries

India

References

Sindhu KN, Sowmyanarayanan TV, Paul A, Babji S, Ajjampur SS, Priyadarshini S, Sarkar R, Balasubramanian KA, Wanke CA, Ward HD, Kang G. Immune response and intestinal permeability in children with acute gastroenteritis treated with Lactobacillus rhamnosus GG: a randomized, double-blind, placebo-controlled trial. Clin Infect Dis. 2014 Apr;58(8):1107-15. doi: 10.1093/cid/ciu065. Epub 2014 Feb 5.

Reference Type: RESULT

PMID: 24501384 (View on PubMed)

Other Identifiers

R03HD057736

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CTRI/2010/091/000339

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCHPROBIO

Identifier Type: -

Identifier Source: org_study_id