Abdominal PainLactoFAPNCT01498666
Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
A study testing L. reuteri protectis in people with Abdominal Pain, run by BioGaia AB at 2 sites in Italy.
Trial summary
The present clinical trial will examine the use of L. reuteri Protectis in children with functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (FAP). Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- L. reuteri protectis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2011to Apr 2013
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- FAP (Functional Abdominal Pain) according to Rome III criteria for
- Child/Adolescent (Rasquin, 2006);
- 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 8-14 years;
- Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
- Ability to understand and comply with the requirements of the trial;
- Stated availability throughout the study period.
Who cannot join
- Chronic illness;
- Surgery of Gastrointestinal tract;
- Any organic symptoms and/or clinical signs of disorder or disease other than FAP;
- Weight loss of 5% or more in body weight over the preceding 3 months;
- Any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance;
- Exposure to any drug or medication (antidepressants, SSRIs, laxatives) in the past 3 months or regular use of this medication;
Show all 10Show 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 clinical trials in the past 3 months;
- Subjects with anemia;
- Subjects with special dietary needs
Trial locations and contacts
2 sites in 1 country.
About this study
The present clinical trial will examine the use of L. reuteri Protectis in children with functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (FAP).
Read the detailed description
Subject will be asked to consume a tablet every day 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.
- Conditions
- Abdominal Pain
- Being tested
- L. reuteri protectis, Placebo tablet
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteri protectisDietary supplement
1 tablet once daily for 4 weeks
Placebo tabletDietary supplement
Also called Placebo
1 tablet once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri protectis tablets | Experimental | one tablet a day for 4 weeks Receives: Dietary Supplement: L. reuteri protectis |
| Placebo tablet | Placebo comparator | one tablet a day for 4 weeks Receives: Dietary Supplement: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Pain frequency measured by a subject diary, in the L. reuteri Protectis group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri Protectis vs. placebo over the 4-week supplementation period.
Measured: 4 weeks
Secondary outcomes (1)
Secondary endpoint
Pain frequency measured by subject diary and expressed as area under the curve, comparing L. reuteri protectis vs. placebo over the initial 2 weeks of the supplementation period. Pain severity measured by the face score system by Wong-Baker at day 14, 28 and 56 (follow up) vs baseline, and area under the curve for weeks 1-4 and 1-2. Treatment success, defined as ≥ 50% reduction in pain frequency in weeks 1-4. Reduction in days of absence from school. Parents' absence from work. Need of rescue medication.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: The recruitment rate was too slow according to study protocol and agreement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim CRO, Italia
- Responsible party
- Sponsor
- Investigators
- Costantino DeGiacomo, MD, Principal investigator, Niguarda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498666
- Sponsor's protocol ID
- Q-PRE-0111-CLI-018
- Acronym
- LactoFAP
- Status last verified
- Dec 2013
- First submitted
- 19 Dec 2011
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
- ClinicalTrials.gov ID
- NCT01498666
- Acronym / sponsor ID
- LactoFAP / Q-PRE-0111-CLI-018
- Conditions
- Abdominal Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment rate was too slow according to study protocol and agreement.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Collaborators
- Sprim CRO, Italia
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 Dec 2011 (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 present clinical trial will examine the use of L. reuteri Protectis in children with functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (FAP).
Detailed description
Subject will be asked to consume a tablet every day 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri protectis tablets | Experimental | Dietary Supplement: L. reuteri protectisone tablet a day for 4 weeks |
| Placebo tablet | Placebo comparator | Dietary Supplement: Placebo tabletone tablet a day for 4 weeks |
Who may qualify
- Ages
- 8 to 14 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 (Rasquin, 2006);
- 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 8-14 years;
Key exclusion criteria (10 listed)
- Chronic illness;
- Surgery of Gastrointestinal tract;
- Any organic symptoms and/or clinical signs of disorder or disease other than FAP;
- Weight loss of 5% or more in body weight over the preceding 3 months;
- Any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance;
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 protectis1 tablet once daily for 4 weeks | Dietary supplement | L. reuteri protectis tablets |
| Placebo tabletAlso: Placebo1 tablet once daily for 4 weeks | Dietary supplement | Placebo tablet |
Primary outcome
Primary endpoint
Time frame: 4 weeks
Pain frequency measured by a subject diary, in the L. reuteri Protectis group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri Protectis vs. placebo over the 4-week supplementation period.
1 secondary outcome
Secondary endpoint
Time frame: 56 days
Results and safety
The study was stopped early (reason given: The recruitment rate was too slow according to study protocol and agreement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
Related trials for Abdominal Pain
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Recruiting
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Multimodal Analgesia, Tramadol
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.
Costantino DeGiacomo, MD principal investigator
Niguarda Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri protectis in people with Abdominal Pain, run by BioGaia AB at 2 sites in Italy.
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 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: stopped early, as of the sponsor's last update on 2 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 2 sites in Italy. 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 was stopped early (reason given: The recruitment rate was too slow according to study protocol and agreement.). Results are not available in the source record.
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?
Primary endpoint (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 2 Jun 2021.