Probiotics for Infectious Diarrhea in Children in South India
Condition: Infectious Gastroenteritis
MeSH terms: Communicable Diseases; Infections; Gastroenteritis; Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): Lactobacillus GG; Inulin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 Billion Organisms Given Mixed In Milk As Food Supplement Once Daily For Four Weeks; Identical appearing capsules containing a powder resembling the LGG to be given as for intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: rotavirus; cryptosporidium; probiotics; intestinal function; immune response