The Role of Lactobacillus Reuteri in Children and Adolescents With Anorexia Nervosa
Condition: Anorexia Nervosa; Constipation
MeSH terms: Constipation; Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether Lactobacillus reuteri could have a beneficial
      role in treatment of children and adolescents with Anorexia nervosa who develop motility
      disorder due to the malnutrition regarding the normalization of the motility, as well as the
      possible role of probiotics on nutritional recovery, especially on bone health.
    

Detailed description: 
      Pediatric patients with AN and constipation referred to gastroenterologist for nutritional
      rehabilitation at the Department of Pediatric Gastroenterology, Hepatology and Nutrition,
      Clinical Hospital Center Sestre Milosrdnice, Zagreb, approximately 30 children, will be asked
      to participate.

      The evaluation of patients will be conducted through APA DSM-V diagnostic criteria for
      anorexia nervosa and Rome III criteria for constipation.

      During the hospitalization all of the patients will receive conventional nutritional
      rehabilitation that is composed of serving normal food under supervision of nurses that
      calculate daily caloric intake through 5-6 meals and according to that additional enteral
      nutrition that consist of polymeric enteral formula. Daily caloric intake is calculated as
      kcal/kg/day and is slowly rising through 2 weeks starting from 80% to the goal of 130% of
      daily energy requirements according to FAO 2004 recommendation.

      Anthropometry measures will be taken at the time of hospitalization and at every visit.

      Normalization of weight is when the Z-score for BMI is less than -1.5 according to CDC
      BMI-growth charts, or normalisation of menstrual cycle is achieved.

      In order to achieve adherence to therapeutic protocol parents will be contacted by phone at
      least once in 7-10 days. Participants will be instructed to keep diary on a daily basis
      (adherence to therapy, stool diary). All patients will return packages with all used, and
      unused product.

      BASELINE -VISIT 1 Randomization at first day of hospitalization. In all patients
      anthropometry will be performed at the time of hospitalization, as well as dual-energy X-ray
      absorptiometry (DEXA) and serum D3 levels at first 2 days of hospitalization as a part of
      routine diagnostic protocol in heavily underweight patients with AN.

      VISIT 2 4 weeks after randomization, at discharge from hospital Anthropometry

      VISIT 3 8 weeks after randomization, 4 weeks after discharge from hospital Anthropometry

      END OF STUDY -VISIT 4 3 months after baseline Anthropometry

      VISIT 5 3 months after the end of study (6 months after baseline) At this point control serum
      D3 levels and DEXA will be performed at all patients Anthropometry

      All the symptoms and daily caloric intake will be monitored using diaries attached to
      protocol.
    

Intervention name(s): Lactobacillus reuteri Protectis DSM17938
Intervention type(s): Dietary Supplement
Intervention description(s): One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Probiotics; Anorexia nervosa; Constipation; Body weight