Probiotics for Infectious Diarrhea in Children in South India

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Christian Medical College, Vellore, India.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Indian Council of Medical Research
Tufts Medical Center
Information provided by:
Christian Medical College, Vellore, India
ClinicalTrials.gov Identifier:
NCT01130792
First received: May 25, 2010
Last updated: December 21, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Infectious Gastroenteritis
Dietary Supplement: Lactobacillus GG
Dietary Supplement: Inulin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Probiotics for Infectious Diarrhea in Children in South India

Resource links provided by NLM:


Further study details as provided by Christian Medical College, Vellore, India:

Primary Outcome Measures:
  • IgG To Rotavirus VP6 Or Cryptosporidial Gp15 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lactulose:mannitol test [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: June 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus GG
LGG once daily for 4 weeks
Dietary Supplement: Lactobacillus GG
10 Billion Organisms Given Mixed In Milk As Food Supplement Once Daily For Four Weeks
Placebo Comparator: Inulin Dietary Supplement: Inulin
Identical appearing capsules containing a powder resembling the LGG to be given as for intervention

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130792

Locations
India
Christian Medical College Recruiting
Vellore, Tamil Nadu, India, 632004
Contact: George Mathew, MS    +9141622284202    princi@cmcvellore.ac.in   
Principal Investigator: Gagandeep Kang, MD,PhD         
Sponsors and Collaborators
Christian Medical College, Vellore, India
Indian Council of Medical Research
Tufts Medical Center
Investigators
Principal Investigator: Gagandeep Kang, MD, PhD Christian Medical College, Vellore, India
Principal Investigator: Honorine D Ward, MD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Gagandeep Kang, Professor, Christian Medical College, Vellore
ClinicalTrials.gov Identifier: NCT01130792     History of Changes
Other Study ID Numbers: MCHPROBIO, R03HD057736, CTRI/2010/091/000339
Study First Received: May 25, 2010
Last Updated: December 21, 2010
Health Authority: India: Indian Council of Medical Research

Keywords provided by Christian Medical College, Vellore, India:
rotavirus
cryptosporidium
probiotics
intestinal function
immune response

Additional relevant MeSH terms:
Communicable Diseases
Infection
Diarrhea
Dysentery
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014