Probiotics for Infectious Diarrhea in Children in South India

NCT01130792 | Completed Phase 1 DMC

• 3 other identifiers: MCHPROBIOR03HD057736CTRI/2010/091/000339
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

rotavirus; cryptosporidium; probiotics; intestinal function; immune response

Outcome Measures

Primary Outcomes (1)

• IgG To Rotavirus VP6 Or Cryptosporidial Gp15

  4 weeks

Secondary Outcomes (1)

• lactulose:mannitol test

  4 weeks

Study Arms (2)

Lactobacillus GG

EXPERIMENTAL

LGG once daily for 4 weeks

Dietary Supplement: Lactobacillus GG

Inulin

PLACEBO COMPARATOR

Dietary Supplement: Inulin

Interventions

Lactobacillus GG DIETARY_SUPPLEMENT

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

Lactobacillus GG

Inulin DIETARY_SUPPLEMENT

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

Inulin

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Medical College, Vellore, India: lead
• Indian Council of Medical Research: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Tufts Medical Center: collaborator

Study Sites (1)

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

Related Publications (1)

• 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.

  PMID: 24501384 RESULT

MeSH Terms

Interventions

Inulin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Gagandeep Kang, MD, PhD

  Christian Medical College, Vellore, India

  PRINCIPAL INVESTIGATOR

• Honorine D Ward, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 26, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

IN (1)