Functional Abdominal Pain (FAP) in ChildrenNCT01719107
Efficacy of Dietary Supplementation With Lactobacilllus Reuteri DSM 17938 on Functional Abdominal Pain (FAP) in Children
A study testing L. reuteri DSM 17938 chewable tablets in people with Functional Abdominal Pain (FAP) in Children, run by Aghia Sophia Children's Hospital of Athens at 3 sites in 3 countries.
Trial summary
The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency and severity in children of 5-16 years old and with diagnosis of FAP. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Functional Abdominal Pain (FAP) in Children
- What is being tested?
- L. reuteri DSM 17938 chewable tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects will be recruited according to the following inclusion criteria:
- FAP (Functional Abdominal Pain) according to Rome III criteria for Child/Adolescent; 1 or more abdominal pain episodes per week over the past 8 weeks
- Informed consent by study participant and at least one parent/legal guardian;
- Age of 5-16 years;
- Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
- Pain frequency of at least 1 or more episodes per week over the preceding 8 weeks;
- Ability to understand and comply with the requirements of the trial;
- Stated availability throughout the study period
Who cannot join
- Subjects presenting with one or more of the following criteria will be excluded from participation in the study:
- Chronic illness;
- Surgery of gastrointestinal tract
- Any symptoms/signs of organic disease and/or any abnormal results of laboratory assays (total blood count, serum glucose, urea, electrolytes, amylase, SGOT, SGPT, anti tTG antibodies, breath H2 test, suggesting disease other than FAP;
- Weight loss of 5% or more in body weight over the preceding 3 months;
- Exposure to any drugs for FAP in the past 2 weeks.
Show all 9Show fewer
- Exposure to probiotics or antibiotics within 4 weeks prior to study; subjects can be included following a wash-out period of 4 weeks.
- Participation in other interventional clinical trials in the past 3 months;
- Subjects with special dietary needs
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Slovenia1 site
University of Ljubljana, Children's Hospital, Department of Gastroenterology
Ljubljana
About this study
The aim of the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency and severity in children of 5-16 years old and with diagnosis of FAP.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study. Subjects between of 5-16 years of age with FAP as defined in the Rome III criteria and with pain severity of at least 40 mm on a 100 mm VAS scale and pain frequency of at least 1 episode per week over the preceding 8 weeks will be recruited. In accordance to the specific Rome III criteria for inclusion, FAP is defined as a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities.
A study questionnaire to record pain and other gastrointestinal symptoms will be used.
One-hundred and six (106) Subjects will be randomized to receive either dietary supplementation with L. reuteri DSM 17938 (2 chewable tablets with breakfast), or the same number of comparable placebo tablets, for 4 weeks. Supplementation will be stopped after 4 weeks, and the subjects will be followed up for an additional 4 weeks. The subjects will complete a diary to record frequency and intensity of pain, use of medication, deviation from the usual diet, physical activities, and absence from school and other activities. Gastrointestinal symptoms are assessed by the GSRS (Gastrointestinal Symptom Rating Score).
Subjects/caregivers will be instructed to maintain the usual diet throughout the study, but not to consume other probiotics (foods or supplements) during the entire study period.
The symptoms diary will be completed daily by the parents and will report information on the frequency of pain episodes, location of pain, presence or absence of associated symptoms, need to take medication for pain and interference with normal activities. The intensity of the symptoms will be assessed by using the Wong-Baker Faces scale.
- Being tested
- L. reuteri DSM 17938 chewable tablets, Placebo chewable tablets
- Keywords
- Functional abdominal pain, Probiotics, Lactobacilus reuteri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteri DSM 17938 chewable tabletsDietary supplement
2 chewable tablets with breakfast for 4 weeks
Placebo chewable tabletsDietary supplement
2 chewable tablets with breakfast for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri DSM 17938 chewable tablets | Active comparator | The active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri DSM 17938 is 1x108 live bacteria (CFU)/tablet. Receives: Dietary Supplement: L. reuteri DSM 17938 chewable tablets |
| Placebo chewable tablets | Placebo comparator | The placebo study product consists of an identical formulation in all respects except that the live bacteria are excluded. Receives: Dietary Supplement: Placebo chewable tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain frequency and severity over the 4-week treatment period.
Reduction in pain frequency measured by a subject diary, in the L. reuteri DSM 17938 group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri DSM 17938 vs placebo over the treatment period.
Reduction in pain severity is assessed using the face score system of Wong-Baker at day 14 and at the end of treatment (day 28)vs. baseline. Area under the pain-intensity curve will be assessed for Weeks 1-4 and Weeks 1-2
Measured: 4 weeks
Secondary outcomes (5)
Reduction in pain frequency and intensity over the 8-week study period
Reduction in pain frequency measured by a subject diary in the L. reuteri group expressed as area under the L. reuteri pain-frequency curve compared to placebo over the initial 2 weeks of the treatment period as well as over the whole study period.
Reduction in pain intensity, measured by the face score system of Wong-Baker at day 14, end of treatment (day 28), and end of follow-up period (day 56) vs baseline. Area under the pain-intensity curve for Weeks 1-4 and Weeks 1-2 will be compared.
Measured: 8 weeks
Reduction in other GI symptoms over the whole study period
Reduction in other GI symptoms as measured by Gastrointestinal Symptom Rating Scoring system. Time points: baseline, day 14, end of treatment and end of follow-up, in the L. reuteri group vs. placebo.
Measured: 8 weeks
Days of absence from school and other activities due to abdominal pain over the whole study period
The number of days of absence from school and other activities due to abdominal pain will be compared between the L. reuteri group vs placebo.
Measured: 8 weeks
Reduction in absence from work by parents over the whole study period
he number of days of absence from work by parents due to abdominal pain of the child will be compared between the L. reuteri group vs placebo.
Measured: 8 weeks
Safety outcome over the whole study period
The number of adverse events will be observed and recorded during the entire study period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Abdominal Pain (FAP) in ChildrenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aghia Sophia Children's Hospital of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Alexandra Papadopoulou, Aghia Sophia Children's Hospital of Athens
- Investigators
- Alexandra Papadopoulou, Hon. Prof. Dr. med., Principal investigator, Athens Interconnected Children's Hospitals "AGIA SOPHIA" and "P & A KYRIAKOU"Hania Szajewska, Prof, Principal investigator, Warsaw UniversityRok Orel, Ass. Prof., Principal investigator, Ljubljana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719107
- Sponsor's protocol ID
- CSUB0003
- Status last verified
- Feb 2016
- First submitted
- 28 Oct 2012
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dietary Supplementation With Lactobacilllus Reuteri DSM 17938 on Functional Abdominal Pain (FAP) in Children
- ClinicalTrials.gov ID
- NCT01719107
- Acronym / sponsor ID
- CSUB0003
- Keywords
- Functional abdominal pain, Probiotics, Lactobacilus reuteri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Aghia Sophia Children's Hospital of AthensUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
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 the study is to investigate the effect of L. reuteri DSM 17938 on pain frequency and severity in children of 5-16 years old and with diagnosis of FAP.
Detailed description
This is a randomized, double-blind, placebo-controlled study. Subjects between of 5-16 years of age with FAP as defined in the Rome III criteria and with pain severity of at least 40 mm on a 100 mm VAS scale and pain frequency of at least 1 episode per week over the preceding 8 weeks will be recruited. In accordance to the specific Rome III criteria for inclusion, FAP is defined as a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities.
A study questionnaire to record pain and other gastrointestinal symptoms will be used.
One-hundred and six (106) Subjects will be randomized to receive either dietary supplementation with L. reuteri DSM 17938 (2 chewable tablets with breakfast), or the same number of comparable placebo tablets, for 4 weeks. Supplementation will be stopped after 4 weeks, and the subjects will be followed up for an additional 4 weeks. The subjects will complete a diary to record frequency and intensity of pain, use of medication, deviation from the usual diet, physical activities, and absence from school and other activities. Gastrointestinal symptoms are assessed by the GSRS (Gastrointestinal Symptom Rating Score).
Subjects/caregivers will be instructed to maintain the usual diet throughout the study, but not to consume other probiotics (foods or supplements) during the entire study period.
The symptoms diary will be completed daily by the parents and will report information on the frequency of pain episodes, location of pain, presence or absence of associated symptoms, need to take medication for pain and interference with normal activities. The intensity of the symptoms will be assessed by using the Wong-Baker Faces scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri DSM 17938 chewable tablets | Active comparator | Dietary Supplement: L. reuteri DSM 17938 chewable tabletsThe active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri DSM 17938 is 1x108 live bacteria (CFU)/tablet. |
| Placebo chewable tablets | Placebo comparator | Dietary Supplement: Placebo chewable tabletsThe placebo study product consists of an identical formulation in all respects except that the live bacteria are excluded. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- FAP (Functional Abdominal Pain) according to Rome III criteria for Child/Adolescent; 1 or more abdominal pain episodes per week over the past 8 weeks
- Informed consent by study participant and at least one parent/legal guardian;
- Age of 5-16 years;
- Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
- Pain frequency of at least 1 or more episodes per week over the preceding 8 weeks;
Key exclusion criteria (9 listed)
- Subjects presenting with one or more of the following criteria will be excluded from participation in the study:
- Chronic illness;
- Surgery of gastrointestinal tract
- Any symptoms/signs of organic disease and/or any abnormal results of laboratory assays (total blood count, serum glucose, urea, electrolytes, amylase, SGOT, SGPT, anti tTG antibodies, breath H2 test, suggesting disease other than FAP;
- Weight loss of 5% or more in body weight over the preceding 3 months;
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 |
|---|---|---|
| L. reuteri DSM 17938 chewable tablets2 chewable tablets with breakfast for 4 weeks | Dietary supplement | L. reuteri DSM 17938 chewable tablets |
| Placebo chewable tablets2 chewable tablets with breakfast for 4 weeks | Dietary supplement | Placebo chewable tablets |
Primary outcome
Abdominal pain frequency and severity over the 4-week treatment period.
Time frame: 4 weeks
Reduction in pain frequency measured by a subject diary, in the L. reuteri DSM 17938 group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri DSM 17938 vs placebo over the treatment period. Reduction in pain severity is assessed using the face score system of Wong-Baker at day 14 and at the end of treatment (day 28)vs. baseline. Area under the pain-intensity curve will be assessed for Weeks 1-4 and Weeks 1-2
5 secondary outcomes
Reduction in pain frequency and intensity over the 8-week study period
Time frame: 8 weeks
Reduction in other GI symptoms over the whole study period
Time frame: 8 weeks
Days of absence from school and other activities due to abdominal pain over the whole study period
Time frame: 8 weeks
Reduction in absence from work by parents over the whole study period
Time frame: 8 weeks
Safety outcome over the whole study period
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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.
Alexandra Papadopoulou, Hon. Prof. Dr. med. principal investigator
Athens Interconnected Children's Hospitals "AGIA SOPHIA" and "P & A KYRIAKOU"
Hania Szajewska, Prof principal investigator
Warsaw University
Rok Orel, Ass. Prof. principal investigator
Ljubljana University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri DSM 17938 chewable tablets in people with Functional Abdominal Pain (FAP) in Children, run by Aghia Sophia Children's Hospital of Athens at 3 sites in 3 countries.
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 8 inclusion and 9 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece, Poland, Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Abdominal pain frequency and severity over the 4-week treatment period. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2016.