An interventional study of L. reuteri DSM 17938 chewable tablets and Placebo chewable tablets in Functional Abdominal Pain (FAP) in Children, sponsored by Aghia Sophia Children's Hospital of Athens. Completed at 3 sites in 3 countries. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2016-02-23.
Sponsored by Aghia Sophia Children's Hospital of Athens · Not applicable, Interventional, and Treatment
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.
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.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
This study's enrollment of 54 is below the median of 70 across 290 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →Aghia Sophia Children's Hospital of Athens is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Subjects will be recruited according to the following inclusion criteria:
Exclusion Criteria:
Subjects presenting with one or more of the following criteria will be excluded from participation in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: L. reuteri DSM 17938 chewable tablets
The placebo study product consists of an identical formulation in all respects except that the live bacteria are excluded.
Dietary Supplement: Placebo chewable tablets
2 chewable tablets with breakfast for 4 weeks
2 chewable tablets with breakfast for 4 weeks
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
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Safety outcome over the whole study period
The number of adverse events will be observed and recorded during the entire study period
Time frame: 8 weeks
The record gives a start of Nov 2012, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Aghia Sophia Children's Hospital of Athens