Irritable Bowel SyndromePROALIFUNNCT03638544
Reduced Content of Gluten Diet on Patients With Irritable Bowel Syndrome (Pro.Ali.Fun.)
A study testing Reduced gluten bread and Pasta compared o normal gluten bread and Pasta in people with Irritable Bowel Syndrome and Gluten Sensitivity, run by University of Bari.
Trial summary
This study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (IBS) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Gluten Sensitivity
- What is being tested?
- Reduced gluten bread and Pasta compared o normal gluten bread and Pasta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2017
- 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 years and older
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 18 years;
- having bowel symptoms (altered bowel habit, lower abdominal pain, bloating, or distention suggestive of IBS), as determined by Rome III criteria.
- Previous exclusion of CD and wheat allergy
Who cannot join
- previous GI malignancy and/or surgery;
- clinically significant cardiovascular, respiratory, endocrine, renal, hematologic or hepatic disease.
- other clinically significant medical condition; pregnancy or lactation; alcohol abuse; drug addiction; severe neurologic or psychiatric disorders; long-term use of corticosteroids or anti-inflammatory drugs
- participation in another clinical trial within 6 months before the onset of this trial.
- -
About this study
Official title: Effect of Wheat Bread and Pasta With Reduced Content of Gluten on Patients With Irritable Bowel Syndrome: Randomized Controlled Cross Over Study
This study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (IBS) patients. Fungal proteases and selected sourdough lactic acid bacteria will be used for making wheat bread and pasta with a reduced content of gluten (RG) (-50% of traditional products). From a technological point of view, the chemical, structural and sensory features of the RG products approached those of the bread and pasta made with normal level of gluten. The efficacy and safety of new products will be compared to traditional bread and pasta by using a double blind randomized, crossover-controlled trial in IBS patients with persistent gastrointestinal symptoms. Patients will follow two weeks of a GFD diet containing RG bread and pasta and two weeks of GFD diet containing Normal Gluten bread and pasta Symptoms severity will be assessed by Irritable Bowel Syndrome Severity Score (IBS-SS), Visual Analogue Scale (VAS), Hospital Anxiety and Depression Scale (HADS) and Irritable Bowel Syndrome Quality of Life (IBS-QoL).
- Conditions
- Irritable Bowel Syndrome, Gluten Sensitivity
- Being tested
- Reduced gluten bread and Pasta compared o normal gluten bread and Pasta
- Medical subject headings
- Irritable Bowel Syndrome, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced gluten bread and Pasta compared o normal gluten bread and PastaDietary supplement
Pasta with low gluten (50% of the normal) content achieved by optimization of techological parameters such as dough yield, time of fermentation and concentration of fungal proteases The gluten reduction is obtained without any other intervention of wheat breeding or the endogenous proteolytic enzymes of flours.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Gluten-Normal Gluten | Active comparator | Not described Receives: Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta |
| Normal Gluten-Reduced Gluten | Active comparator | Not described Receives: Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of IBS symptoms measured by Irritable Bowel Syndrome-Severity Score (IBS-SS)
Change in IBS Severity Score (IBS-SS) between reduced gluten content diet and standard gluten content diet. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and "300 respectively. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300, and >300, respectively.
Measured: two weeks of each different diet interspersed by one week of wash out. The questionnaire will be completed ones a week.
Change of IBS severity measured by Visual analogue scale (VAS)
Change of severity of IBS symptoms measured by Visual analogue scale (VAS) between reduced gluten content diet and standard gluten content diet. The 0-10 mm VAS scale (0 no pain, 10 worst possible pain) included a horizontal color gradient (green-red).
Measured: Two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a day.
Secondary outcomes (1)
Change of Quality of life scores
Irritable Bowel Syndrome Quality of Life (IBS-QoL) between reduced gluten content diet and standard gluten content diet.
Measured: two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Model description
- Double blind placebo controlled Gluten Sensitivity
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruggiero Francavilla, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638544
- Sponsor's protocol ID
- PROALIFUN
- Acronym
- PROALIFUN
- Status last verified
- Aug 2018
- First submitted
- 11 Jul 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wheat Bread and Pasta With Reduced Content of Gluten on Patients With Irritable Bowel Syndrome: Randomized Controlled Cross Over Study
- ClinicalTrials.gov ID
- NCT03638544
- Acronym / sponsor ID
- PROALIFUN / PROALIFUN
- Conditions
- Irritable Bowel Syndrome, Gluten Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Aug 2018 (actual)
- 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.
This study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (IBS) patients. Fungal proteases and selected sourdough lactic acid bacteria will be used for making wheat bread and pasta with a reduced content of gluten (RG) (-50% of traditional products). From a technological point of view, the chemical, structural and sensory features of the RG products approached those of the bread and pasta made with normal level of gluten. The efficacy and safety of new products will be compared to traditional bread and pasta by using a double blind randomized, crossover-controlled trial in IBS patients with persistent gastrointestinal symptoms. Patients will follow two weeks of a GFD diet containing RG bread and pasta and two weeks of GFD diet containing Normal Gluten bread and pasta Symptoms severity will be assessed by Irritable Bowel Syndrome Severity Score (IBS-SS), Visual Analogue Scale (VAS), Hospital Anxiety and Depression Scale (HADS) and Irritable Bowel Syndrome Quality of Life (IBS-QoL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind placebo controlled Gluten Sensitivity
| Arm | Type | Receives |
|---|---|---|
| Reduced Gluten-Normal Gluten | Active comparator | Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta |
| Normal Gluten-Reduced Gluten | Active comparator | Dietary Supplement: Reduced gluten bread and Pasta compared o normal gluten bread and Pasta |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age above 18 years;
- having bowel symptoms (altered bowel habit, lower abdominal pain, bloating, or distention suggestive of IBS), as determined by Rome III criteria.
- Previous exclusion of CD and wheat allergy
Key exclusion criteria (5 listed)
- previous GI malignancy and/or surgery;
- clinically significant cardiovascular, respiratory, endocrine, renal, hematologic or hepatic disease.
- other clinically significant medical condition; pregnancy or lactation; alcohol abuse; drug addiction; severe neurologic or psychiatric disorders; long-term use of corticosteroids or anti-inflammatory drugs
- participation in another clinical trial within 6 months before the onset of this trial.
- -
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 |
|---|---|---|
| Reduced gluten bread and Pasta compared o normal gluten bread and PastaPasta with low gluten (50% of the normal) content achieved by optimization of techological parameters such as dough yield, time of fermentation and concentration of fungal proteases The gluten reduction is obtained without any other intervention of wheat breeding or the endogenous proteolytic enzymes of flours. | Dietary supplement | Normal Gluten-Reduced Gluten, Reduced Gluten-Normal Gluten |
Primary outcome
Change in Severity of IBS symptoms measured by Irritable Bowel Syndrome-Severity Score (IBS-SS)
Time frame: two weeks of each different diet interspersed by one week of wash out. The questionnaire will be completed ones a week.
Change in IBS Severity Score (IBS-SS) between reduced gluten content diet and standard gluten content diet. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and "300 respectively. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300, and >300, respectively.
Change of IBS severity measured by Visual analogue scale (VAS)
Time frame: Two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a day.
Change of severity of IBS symptoms measured by Visual analogue scale (VAS) between reduced gluten content diet and standard gluten content diet. The 0-10 mm VAS scale (0 no pain, 10 worst possible pain) included a horizontal color gradient (green-red).
1 secondary outcome
Change of Quality of life scores
Time frame: two weeks of each different diet interspersed by one week of wash out. The scale will be completed ones a week.
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 20 Aug 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced gluten bread and Pasta compared o normal gluten bread and Pasta in people with Irritable Bowel Syndrome and Gluten Sensitivity, run by University of Bari.
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 3 inclusion and 5 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in Severity of IBS symptoms measured by Irritable Bowel Syndrome-Severity Score (IBS-SS) (time frame: two weeks of each different diet interspersed by one week of wash out. The questionnaire will be completed ones a week.). The study lists 2 primary outcomes in all. 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 20 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.