The Role of Lactobacillus Reuteri in Children and Adolescents With Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by BioGaia AB
Sponsor:
Information provided by (Responsible Party):
BioGaia AB
ClinicalTrials.gov Identifier:
NCT02004288
First received: December 2, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Anorexia Nervosa
Constipation
Dietary Supplement: Lactobacillus reuteri Protectis DSM17938
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: The Role of Lactobacillus Reuteri in Nutritional Recovery and Treatment of Constipation in Children and Adolescents With Anorexia Nervosa - Randomised, Double Blind, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by BioGaia AB:

Primary Outcome Measures:
  • Drop out from Rome III criteria for constipation [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • normalization of body weight [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus reuteri Protectis DSM17938
One chewable tablet per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit)
Dietary Supplement: Lactobacillus reuteri Protectis DSM17938
One chewable tablet with L. reuteri or placebo taken once a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.
Placebo Comparator: Placebo
One chewable tablet with placebo per day
Dietary Supplement: Lactobacillus reuteri Protectis DSM17938
One chewable tablet with L. reuteri or placebo taken once a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients with Anorexia nervosa and constipation, aged 8-18 years

Exclusion Criteria:

  • AN and constipation present for less than 3 month prior to hospitalization
  • any disease that affects GI or other systems other than AN or functional constipation
  • chronic disorder other than AN
  • receiving probiotic and/or prebiotic products 14 days prior to enrolment
  • receiving antibiotics 14 days prior to enrolment
  • constipation prior AN
  • receiving laxative as a therapy for constipation or abuse of laxative to lose weight prior to enrolment
  • extraintestinal symptoms: fever, rash
  • abnormalities in laboratory findings
  • abnormalities in clinical findings: organomegaly, perianal disease
  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: NCT02004288

Contacts
Contact: Orjena Zaja Franulovic, MD, PhD + 385993787277 orjenazf@yahoo.com
Contact: Tatjana Lesar, MD

Locations
Croatia
Pediatric Department Clinical Hospital Centre Sestre milosrdnice Gastroenterology, Hepatology and Nutrition Ward Recruiting
Zagreb, Croatia
Contact: Orjena Zaja franulovic, PhD, MD    +38513787917    orjenazf@yahoo.com   
Principal Investigator: Orjena Zaja Franulovic, MD, PhD         
Sponsors and Collaborators
BioGaia AB
Investigators
Principal Investigator: Orjena Zaja Franulovic, MD, PhD Department of Pediatric Gastroenterology, Hepatology and Nutrition Clinical Hospital Centre Sestre milosrdnice Vinogradska 29 Zagreb, Croatia
  More Information

No publications provided

Responsible Party: BioGaia AB
ClinicalTrials.gov Identifier: NCT02004288     History of Changes
Other Study ID Numbers: CSUB0083
Study First Received: December 2, 2013
Last Updated: December 13, 2013
Health Authority: Croatia: Ethics Committee

Keywords provided by BioGaia AB:
Probiotics
Anorexia nervosa
Constipation
Body weight

Additional relevant MeSH terms:
Anorexia
Constipation
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014