Infectious Gastroenteritis Clinical Trial
Official title:
Probiotics for Infectious Diarrhea in Children in South India
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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