Anorexia NervosaNCT02004288
The Role of Lactobacillus Reuteri in Children and Adolescents With Anorexia Nervosa
A study testing Lactobacillus reuteri Protectis DSM17938 in people with Anorexia Nervosa and Constipation, run by BioGaia AB at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Anorexia Nervosa, Constipation
- What is being tested?
- Lactobacillus reuteri Protectis DSM17938
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteCroatia
- Study dates
- Dec 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with Anorexia nervosa and constipation, aged 8-18 years
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Pediatric Department Clinical Hospital Centre Sestre milosrdnice Gastroenterology, Hepatology and Nutrition Ward
Zagreb
About this study
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
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.
Read the 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.
- Conditions
- Anorexia Nervosa, Constipation
- Being tested
- Lactobacillus reuteri Protectis DSM17938
- Keywords
- Probiotics, Anorexia nervosa, Constipation, Body weight
- Medical subject headings
- Anorexia Nervosa, Constipation, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri Protectis DSM17938Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri Protectis DSM17938 | Experimental | One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit) Receives: Dietary Supplement: Lactobacillus reuteri Protectis DSM17938 |
| Placebo | Placebo comparator | One chewable tablet twice per day with placebo per day Receives: Dietary Supplement: Lactobacillus reuteri Protectis DSM17938 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Drop Out From Rome III Criteria for Constipation
Drop out from Rome III criteria for constipation: Yes / No. According to Rome III, a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on >25% of defecations; b) lumpy or hard stools on >25% of defecations; c) sensation of incomplete evacuation on >25% of defecations; d) sensation of anorectal obstruction/blockage on >25% of defecations; e) manual maneuvers on >25% of defecations; and f) less than 3 defecations per week.
Measured: 3 month
Secondary outcomes (1)
Normalization of Body Weight
normalization of body weight- 90% of premorbid weight, or ≥10. centile for BMI (according to the WHO growth charts)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orjena Zaja Franulovic, MD, PhD, Principal investigator, Center for Eating disorders Sestre milosrdnice University hospital Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004288
- Sponsor's protocol ID
- CSUB0083
- Status last verified
- May 2021
- First submitted
- 2 Dec 2013
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zaja O, Fiolic M, Cuk MC, Tiljak MK. "The role of L. reuteri DSM17938 in nutritional recovery and treatment of constipation in children and adolescents with anorexia nervosa - a randomized, double blind, placebo controlled study". Clin Nutr ESPEN. 2021 Dec;46:47-53. doi: 10.1016/j.clnesp.2021.08.016. Epub 2021 Sep 8.
PubMed 34857236
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02004288
- Acronym / sponsor ID
- CSUB0083
- Conditions
- Anorexia Nervosa, Constipation
- Keywords
- Probiotics, Anorexia nervosa, Constipation, Body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri Protectis DSM17938 | Experimental | Dietary Supplement: Lactobacillus reuteri Protectis DSM17938One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit) |
| Placebo | Placebo comparator | Dietary Supplement: Lactobacillus reuteri Protectis DSM17938One chewable tablet twice per day with placebo per day |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients with Anorexia nervosa and constipation, aged 8-18 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus reuteri Protectis DSM17938One 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. | Dietary supplement | Lactobacillus reuteri Protectis DSM17938, Placebo |
Primary outcome
Number of Participants That Drop Out From Rome III Criteria for Constipation
Time frame: 3 month
Drop out from Rome III criteria for constipation: Yes / No. According to Rome III, a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on >25% of defecations; b) lumpy or hard stools on >25% of defecations; c) sensation of incomplete evacuation on >25% of defecations; d) sensation of anorectal obstruction/blockage on >25% of defecations; e) manual maneuvers on >25% of defecations; and f) less than 3 defecations per week.
1 secondary outcome
Normalization of Body Weight
Time frame: 6 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34857236Zaja O, Fiolic M, Cuk MC, Tiljak MK. "The role of L. reuteri DSM17938 in nutritional recovery and treatment of constipation in children and adolescents with anorexia nervosa - a randomized, double blind, placebo controlled study". Clin Nutr ESPEN. 2021 Dec;46:47-53. doi: 10.1016/j.clnesp.2021.08.016. Epub 2021 Sep 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orjena Zaja Franulovic, MD, PhD principal investigator
Center for Eating disorders Sestre milosrdnice University hospital Zagreb, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri Protectis DSM17938 in people with Anorexia Nervosa and Constipation, run by BioGaia AB at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Drop Out From Rome III Criteria for Constipation (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.