IBS in Celiac DeseaseProCelNCT01699191
Probiotics for the Treatment of Irritable Bowel Syndrome in Celiac Patients
A study testing Probiotic in people with IBS in Celiac Desease, run by University of Bari at 1 site in Italy.
Trial summary
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS in Celiac Desease
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2012to Jan 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Celiac patients aged between 18 and 65 years
- Diagnosis of IBS on the basis of Rome III criteria
- GFD
- Informed consent
Who cannot join
- Previous sigmoidoscopy or colonoscopy in the past 5 years
- Known concomitant organic diseases, including inflammatory bowel disease and other systemic diseases significant
- Treatment with antispasmodic drugs within the previous month
- Are pregnant
- Immunodeficiency
- Previous abdominal surgery, with the exception of the hernia repair or appendectomy
Show all 9Show fewer
- Treatment with antibiotics within the previous month
- Treatment with probiotics and / or prebiotics within the previous month
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Clinical studies show that patients meeting the criteria for diagnosis for IBS have greater probability for being affected by celiac desease if compared to controls without IBS. Since one of the causes attributed to the onset of IBS is the modified flora gut, it is interesting to determine the beneficial effects that probiotics may have on gastrointestinal symptoms in celiac disease patients. The goal of the present study is to determine whether oral administration of a probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and Bifidobacterium animalis under randomized, double-blind, placebo-controlled conditions would improve symptoms of adult celiac patients with IBS.
Read the detailed description
This is a randomized, double blind study, placebo-controlled, carried out in three departments of gastroenterology in Southern Italy (Bari, Taranto e Castellana Grotte).
Celiac patients with Irritable Bowel Syndrome will considered eligible for inclusion. They will be between 18 and 65 years old and they will be in GFD for at least 2 year.
Will be excluded from the study patients with previous abdominal surgery, chronic disease, alarm signs of organic conditions, treatment with probiotics, prebiotics, antibiotics and antispasmodics in the previous month, immunodeficiency, pregnancy.
The size of the sample, which must show a benefit greater than 25% compared to placebo (untreated group that usually able to respond positive in 20% of cases), will require 58 patients per arm to ensure a power of 90% with an alpha error of 0.5.
Patient will be assigned consecutive numbers, starting with the lowest number available, and randomly assigned, with the use of a computer generated randomisation list using permuted block design, to receive orally either a probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and Bifidobacterium animalis or placebo (sachets identical in taste and appearance to the active study product except for the absence of probiotic mixture) once a day.
The study consists of three phases:
- phase of "running-in" of two weeks to reduce the possibility of a next significant placebo effect in which the patient should not take no product;
- supplementation for 6 weeks in which the patient will take one packet per day of placebo or active product;
- follow-up of 6 weeks.
Enrolled patients will be entered sequentially to receive the assigned treatment. Boxes containing placebo will have the same shape, dimension, indication and appearance as those containing the viable probiotic mixture and will be provided by the probiotic producer (Moviscom Srl, Rome, Italy) which ensure that the study is blinded for investigators and patients. Group assignment will be concealed from participants and investigators.
During the duration of the trial (w1- w14) patients will record gastrointestinal symptoms on weekly diary. During the same time will compiled, every two week, the Gastrointestinal symptom rating score (GSRS), that consists of a 15-point questionnaire to assess severity and frequency of symptoms validated by Svedlund et al.. For all patients will be collected, at T = 0 and T = 42 days, stool samples on which will be performed the extraction of DNA and RNA for a possible assessment of the intestinal microflora. Bacteria DNA in stools will be extracted and stored at -80°C for future analysis. At the end of the study, for patients who have achieved the primary objective will be made specific identification of the intestinal microflora for verify any amendments.
The compliance to the study will be demonstrated according to the number of sachets consumed by the patient during the 6 weeks of administration, and on the basis of the compilation of the questionnaires provided by the protocol.
Outcome Measures Primary outcome will be the incidence in IBS in celiac patients receiving probiotics as compared to those receiving placebo. We have chosen pain as the primary outcome measure, in line with the proposed points-to-consider for IBS trials.
IBS will be diagnosed and categorised according to ROME III criteria. Secondary outcomes are: 1) evaluation of frequency/severity of symptoms according to treatment arm; 2) modification of intestinal microbiota.
The analysis of the intestinal microbiota of these informative cases will help to assess whether there is a intestinal microbiota suggestive of future inset of IBS and ability of our probiotic mixture to stabilize the intestinal microbiota.
Adverse Events and Disallowed Medication Adverse events will be monitored throughout the study. Patients will not allowed to consume any probiotic other than those provided and they will be invited to continue their eating and physical exercise habits.
- Conditions
- IBS in Celiac Desease
- Being tested
- Probiotic, Placebo
- Keywords
- Irritable Bowel Syndrome, Celiac Desease, Probiotic, Lactobacillus plantarum, Bifidobacterium breve, Lactobacillus casei, Bifidobacterium animalis
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Mixture | Active comparator | Probiotic mixture Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of abdominal pain in celiac patients
Primary outcome will be the incidence in IBS in celiac patients receiving probiotics mixture as compared to those receiving placebo.
IBS will be diagnosed and categorised according to ROME III criteria.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS in Celiac DeseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruggiero Francavilla, University of Bari
- Investigators
- Ruggiero Francavilla, Principal investigator, DEPARTMENT OF BIOMEDICINA ETA' EVOLUTIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699191
- Sponsor's protocol ID
- ProCeDo
- Acronym
- ProCel
- Status last verified
- Oct 2012
- First submitted
- 1 Oct 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for the Treatment of Irritable Bowel Syndrome in Celiac Patients
- ClinicalTrials.gov ID
- NCT01699191
- Acronym / sponsor ID
- ProCel / ProCeDo
- Conditions
- IBS in Celiac Desease
- Keywords
- Irritable Bowel Syndrome, Celiac Desease, Probiotic, Lactobacillus plantarum, Bifidobacterium breve, Lactobacillus casei, Bifidobacterium animalis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 3 Oct 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.
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Clinical studies show that patients meeting the criteria for diagnosis for IBS have greater probability for being affected by celiac desease if compared to controls without IBS. Since one of the causes attributed to the onset of IBS is the modified flora gut, it is interesting to determine the beneficial effects that probiotics may have on gastrointestinal symptoms in celiac disease patients. The goal of the present study is to determine whether oral administration of a probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and Bifidobacterium animalis under randomized, double-blind, placebo-controlled conditions would improve symptoms of adult celiac patients with IBS.
Detailed description
This is a randomized, double blind study, placebo-controlled, carried out in three departments of gastroenterology in Southern Italy (Bari, Taranto e Castellana Grotte).
Celiac patients with Irritable Bowel Syndrome will considered eligible for inclusion. They will be between 18 and 65 years old and they will be in GFD for at least 2 year.
Will be excluded from the study patients with previous abdominal surgery, chronic disease, alarm signs of organic conditions, treatment with probiotics, prebiotics, antibiotics and antispasmodics in the previous month, immunodeficiency, pregnancy.
The size of the sample, which must show a benefit greater than 25% compared to placebo (untreated group that usually able to respond positive in 20% of cases), will require 58 patients per arm to ensure a power of 90% with an alpha error of 0.5.
Patient will be assigned consecutive numbers, starting with the lowest number available, and randomly assigned, with the use of a computer generated randomisation list using permuted block design, to receive orally either a probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and Bifidobacterium animalis or placebo (sachets identical in taste and appearance to the active study product except for the absence of probiotic mixture) once a day.
The study consists of three phases:
- phase of "running-in" of two weeks to reduce the possibility of a next significant placebo effect in which the patient should not take no product;
- supplementation for 6 weeks in which the patient will take one packet per day of placebo or active product;
- follow-up of 6 weeks.
Enrolled patients will be entered sequentially to receive the assigned treatment. Boxes containing placebo will have the same shape, dimension, indication and appearance as those containing the viable probiotic mixture and will be provided by the probiotic producer (Moviscom Srl, Rome, Italy) which ensure that the study is blinded for investigators and patients. Group assignment will be concealed from participants and investigators.
During the duration of the trial (w1- w14) patients will record gastrointestinal symptoms on weekly diary. During the same time will compiled, every two week, the Gastrointestinal symptom rating score (GSRS), that consists of a 15-point questionnaire to assess severity and frequency of symptoms validated by Svedlund et al.. For all patients will be collected, at T = 0 and T = 42 days, stool samples on which will be performed the extraction of DNA and RNA for a possible assessment of the intestinal microflora. Bacteria DNA in stools will be extracted and stored at -80°C for future analysis. At the end of the study, for patients who have achieved the primary objective will be made specific identification of the intestinal microflora for verify any amendments.
The compliance to the study will be demonstrated according to the number of sachets consumed by the patient during the 6 weeks of administration, and on the basis of the compilation of the questionnaires provided by the protocol.
Outcome Measures Primary outcome will be the incidence in IBS in celiac patients receiving probiotics as compared to those receiving placebo. We have chosen pain as the primary outcome measure, in line with the proposed points-to-consider for IBS trials.
IBS will be diagnosed and categorised according to ROME III criteria. Secondary outcomes are: 1) evaluation of frequency/severity of symptoms according to treatment arm; 2) modification of intestinal microbiota.
The analysis of the intestinal microbiota of these informative cases will help to assess whether there is a intestinal microbiota suggestive of future inset of IBS and ability of our probiotic mixture to stabilize the intestinal microbiota.
Adverse Events and Disallowed Medication Adverse events will be monitored throughout the study. Patients will not allowed to consume any probiotic other than those provided and they will be invited to continue their eating and physical exercise habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Mixture | Active comparator | Dietary Supplement: ProbioticProbiotic mixture |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Celiac patients aged between 18 and 65 years
- Diagnosis of IBS on the basis of Rome III criteria
- GFD
- Informed consent
Key exclusion criteria (9 listed)
- Previous sigmoidoscopy or colonoscopy in the past 5 years
- Known concomitant organic diseases, including inflammatory bowel disease and other systemic diseases significant
- Treatment with antispasmodic drugs within the previous month
- Are pregnant
- Immunodeficiency
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 |
|---|---|---|
| Probiotic | Dietary supplement | Probiotic Mixture |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Treatment of abdominal pain in celiac patients
Time frame: 14 weeks
Primary outcome will be the incidence in IBS in celiac patients receiving probiotics mixture as compared to those receiving placebo. IBS will be diagnosed and categorised according to ROME III criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
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.
Ruggiero Francavilla principal investigator
DEPARTMENT OF BIOMEDICINA ETA' EVOLUTIVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with IBS in Celiac Desease, run by University of Bari at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 3 Oct 2012. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruggiero Francavilla (0805592963, rfrancavilla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of abdominal pain in celiac patients (time frame: 14 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 3 Oct 2012.