IBS - Irritable Bowel SyndromeNCT05616429
Alcat Based Elimination Diet for the Treatment of Irritable Bowel Syndrome; a Randomized Double Blind Sham Control Trial
A study testing Alcat based personal diet and Standard balanced diet in people with IBS - Irritable Bowel Syndrome, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Irritable bowel syndrome (IBS) is the most common GI condition with global prevalence ranging between 10-20%. Although the exact cause is not known there are increasing insights concerning the possible multifactorial etiology including low grade inflammation, neuromodulation, dysbiosis, impaired integrity of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Alcat based personal diet and Standard balanced diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2020to 15 May 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only adults (>18 years of age) meeting the Rome 4 Criteria for IBS D/M/U and who are willing to adhere to diet restrictions, will be eligible for entry into the study.
- Patients with 'warning symptoms' (e.g., unexplained weight loss, history of GI cancer or inflammatory bowel disease, rectal bleeding etc) will be required to have had a detailed workup to exclude organic pathology prior to enrollment.
- Participants will be allowed to continue their IBS medications (e.g., fiber, anti-spasmodics, antidepressants, loperamide, etc.) as long as they had been on stable doses for at least 30 days prior to entering the study and agreed not to change medications or dosages during the trial.
- In addition, patients will be required to have active symptoms at the entry of the study as defined by having an IBSSSS score of >150 (0-500 scale).
Who cannot join
- Patients will be excluded if they fulfill ROME 4 IBS C criteria
- Have an inflammatory bowel disease, celiac or other inflammatory or gut disorder other than IBS.
- Have active malignancy of any kind
- If they are not able to eat PO
- If they are Using NSAIDS more than once per month and within the 4 weeks prior to inclusion
- If C reactive protein is above 2 times the normal value or if stool Calprotectin is above 200mcg/gr
- If they had recent antibiotic use (within 1 month). -
Trial locations and contacts
1 site in 1 country.
About this study
Irritable bowel syndrome (IBS) is the most common GI condition with global prevalence ranging between 10-20%. Although the exact cause is not known there are increasing insights concerning the possible multifactorial etiology including low grade inflammation, neuromodulation, dysbiosis, impaired integrity of the intestinal barrier and more.
Currently, it is believed that changes in the microbiota may activate mucosal innate immune responses, resulting in increased epithelial permeability, activated nociceptive sensory pathways, and dysregulation of the enteric nervous system.
Read more
Nearly two thirds of patients with IBS perceive their GI symptoms to be food related, hence, food intolerance may be important factor in the pathogenesis. Diet is a part of IBS treatment but adherence, on the one hand, and restriction, on the other, remain a major problem. [Chey WD, Am J Gastroenterol,2016].
Confocal laser endomicroscopy (CLE) is a technique that permits real-time detection and quantification of changes in intestinal tissues and cells, including increases in intraepithelial lymphocytes and fluid extravasation through epithelial leaks.
Based on CLE analysis of IBS patients with a suspected food intolerance, exposure to candidate food antigens caused immediate breaks, increased intervillous spaces, and increased IELs in the intestinal mucosa. These changes are associated with patient responses to exclusion diets. [Fritscher-Ravens A et al, Gastroenterology. 2019, Gastroenterology. 2014] This technic, also efficient according to former studies, is costly and invasive.
The Alcat Test is a lab based immune stimulation test in which a patient's WBC's (white blood cell) are challenged with various substances including foods, additives, colorings, chemicals, medicinal herbs, functional foods, molds and pharmaceutical compounds. The Alcat Test objectively classifies a patient's response to each test substance as reactive, borderline or non-reactive. Based on these classifications, a customized elimination/rotation diet may be designed.
Read the detailed description
Diet therapies for IBS are becoming an important part of the treatment for patients with IBS [Lenhart A et al, J Neurogastroenterology Motil 2018] There are many types of elimination diets utilized by patients with IBS including personalized diets based upon mediator release testing and IgG (immunoglobulin G) antibody. These diets have the potential for tailor made personal diet but currently have little or no clinical evidence for efficacy.
Diet therapies, like medical therapies for IBS, should be properly evaluated in appropriate designed clinical trials.
It is also important to protect our patients with IBS from potentially ineffective, costly and unsafe intervention.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Alcat based personal diet, Standard balanced diet, usual care
- 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.
Alcat based personal dietDietary supplement
Alcat based personalized diet with dietician supervision and follow-up + usual care
Standard balanced dietDietary supplement
"Sham" standard balanced diet with dietician supervision and follow up + usual care.
usual careOther
usual care
| Study group | Role | What they receive |
|---|---|---|
| Alcat based personal diet | Experimental | Not described Receives: Dietary Supplement: Alcat based personal diet; Other: usual care |
| Standard balanced diet | Sham comparator | Not described Receives: Dietary Supplement: Standard balanced diet; Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome (IBS) Symptom Severity Scale questionnaire
decrease of 50 points. Values range: 0-500
Measured: 8 weeks
Secondary outcomes (6)
Irritable Bowel Syndrome Global Symptom Assessment (IBS-GSA) questionnaire
Compared to how you felt then, how would you rate your overall IBS symptoms during the past week? Possible answers are one of the following: Significantly relieved (+3); Moderately relieved (+2); A little bit relieved (+1); Unchanged (0); A little bit worse (-1); Moderately worse (-2); Significantly worse (-3).
[ Rome Foundation]
Measured: 4 and 8 weeks
Abnormal laboratory value - bio marker
decrease level - CRP (C reactive protein) milligrams per liter (mg/L)
Measured: 8 weeks
Monitoring serum level of Syndecan-1 (Sdc1) ng/mL
Syndecan-1 (Sdc-1) is a type 1 transmembrane heparan sulfate proteoglycans that are implicated in maintenance of intestinal epithelial barrier. Sdc-1 is predominantly expressed by plasma cells and mucosal epithelial cells, such as intestinal epithelial cells.
Changes of Sdc1 level in sera will be assessed primarily to the diet intervention and at the end of the diet after 8 weeks
Measured: 8 weeks
Irritable Bowel Syndrome (IBS) Adequate Relief questionnaire
IBS-Adequate Relief (IBS-AR) is a dichotomous single item that asks participants "Over the past week have you had adequate relief of your IBS symptoms?
Measured: up to 8 weeks
Irritable Bowel Syndrome Quality of life questionnaire - specific for IBS (IBS-QoL)
Changes from baseline to Week 8 in IBS-QOL total and subscale scores . Values: 34-170
Measured: 8 weeks
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1) Substantially Worse, 2) Moderately Worse, 3)Slightly Worse, 4) No Change, 5) Slightly Improved, 6) Moderately Improved or 7) Substantially Improved. A responder is defined as a patient who answered "moderately improved" or "substantially improved".
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Aug 2020
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Double blind randomized clinical trial (RCT) comparing Alcat based personal diet for the treatment of IBS versus "sham" standard balanced diet
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Cell science systems
- Responsible party
- Principal investigator, Dr. Tal Engel, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616429
- Sponsor's protocol ID
- 6834-20-TA-CTIL
- Status last verified
- May 2023
- First submitted
- 26 Oct 2022
- Last updated
- 23 May 2023
- Results posted
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcat Based Elimination Diet for the Treatment of Irritable Bowel Syndrome; a Randomized Double Blind Sham Control Trial
- ClinicalTrials.gov ID
- NCT05616429
- Acronym / sponsor ID
- 6834-20-TA-CTIL
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Cell science systems
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 15 Nov 2022 (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.
Irritable bowel syndrome (IBS) is the most common GI condition with global prevalence ranging between 10-20%. Although the exact cause is not known there are increasing insights concerning the possible multifactorial etiology including low grade inflammation, neuromodulation, dysbiosis, impaired integrity of the intestinal barrier and more.
Currently, it is believed that changes in the microbiota may activate mucosal innate immune responses, resulting in increased epithelial permeability, activated nociceptive sensory pathways, and dysregulation of the enteric nervous system.
Nearly two thirds of patients with IBS perceive their GI symptoms to be food related, hence, food intolerance may be important factor in the pathogenesis. Diet is a part of IBS treatment but adherence, on the one hand, and restriction, on the other, remain a major problem. [Chey WD, Am J Gastroenterol,2016].
Confocal laser endomicroscopy (CLE) is a technique that permits real-time detection and quantification of changes in intestinal tissues and cells, including increases in intraepithelial lymphocytes and fluid extravasation through epithelial leaks.
Based on CLE analysis of IBS patients with a suspected food intolerance, exposure to candidate food antigens caused immediate breaks, increased intervillous spaces, and increased IELs in the intestinal mucosa. These changes are associated with patient responses to exclusion diets. [Fritscher-Ravens A et al, Gastroenterology. 2019, Gastroenterology. 2014] This technic, also efficient according to former studies, is costly and invasive.
The Alcat Test is a lab based immune stimulation test in which a patient's WBC's (white blood cell) are challenged with various substances including foods, additives, colorings, chemicals, medicinal herbs, functional foods, molds and pharmaceutical compounds. The Alcat Test objectively classifies a patient's response to each test substance as reactive, borderline or non-reactive. Based on these classifications, a customized elimination/rotation diet may be designed.
Detailed description
Diet therapies for IBS are becoming an important part of the treatment for patients with IBS [Lenhart A et al, J Neurogastroenterology Motil 2018] There are many types of elimination diets utilized by patients with IBS including personalized diets based upon mediator release testing and IgG (immunoglobulin G) antibody. These diets have the potential for tailor made personal diet but currently have little or no clinical evidence for efficacy.
Diet therapies, like medical therapies for IBS, should be properly evaluated in appropriate designed clinical trials.
It is also important to protect our patients with IBS from potentially ineffective, costly and unsafe intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind randomized clinical trial (RCT) comparing Alcat based personal diet for the treatment of IBS versus "sham" standard balanced diet
| Arm | Type | Receives |
|---|---|---|
| Alcat based personal diet | Experimental | Dietary Supplement: Alcat based personal diet, Other: usual care |
| Standard balanced diet | Sham comparator | Dietary Supplement: Standard balanced diet, Other: usual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Only adults (>18 years of age) meeting the Rome 4 Criteria for IBS D/M/U and who are willing to adhere to diet restrictions, will be eligible for entry into the study.
- Patients with 'warning symptoms' (e.g., unexplained weight loss, history of GI cancer or inflammatory bowel disease, rectal bleeding etc) will be required to have had a detailed workup to exclude organic pathology prior to enrollment.
- Participants will be allowed to continue their IBS medications (e.g., fiber, anti-spasmodics, antidepressants, loperamide, etc.) as long as they had been on stable doses for at least 30 days prior to entering the study and agreed not to change medications or dosages during the trial.
- In addition, patients will be required to have active symptoms at the entry of the study as defined by having an IBSSSS score of >150 (0-500 scale).
Key exclusion criteria (7 listed)
- Patients will be excluded if they fulfill ROME 4 IBS C criteria
- Have an inflammatory bowel disease, celiac or other inflammatory or gut disorder other than IBS.
- Have active malignancy of any kind
- If they are not able to eat PO
- If they are Using NSAIDS more than once per month and within the 4 weeks prior to inclusion
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 |
|---|---|---|
| Alcat based personal dietAlcat based personalized diet with dietician supervision and follow-up + usual care | Dietary supplement | Alcat based personal diet |
| Standard balanced diet"Sham" standard balanced diet with dietician supervision and follow up + usual care. | Dietary supplement | Standard balanced diet |
| usual careusual care | Other | Alcat based personal diet, Standard balanced diet |
Primary outcome
Irritable Bowel Syndrome (IBS) Symptom Severity Scale questionnaire
Time frame: 8 weeks
decrease of 50 points. Values range: 0-500
6 secondary outcomes
Irritable Bowel Syndrome Global Symptom Assessment (IBS-GSA) questionnaire
Time frame: 4 and 8 weeks
Abnormal laboratory value - bio marker
Time frame: 8 weeks
Monitoring serum level of Syndecan-1 (Sdc1) ng/mL
Time frame: 8 weeks
Irritable Bowel Syndrome (IBS) Adequate Relief questionnaire
Time frame: up to 8 weeks
Irritable Bowel Syndrome Quality of life questionnaire - specific for IBS (IBS-QoL)
Time frame: 8 weeks
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
Time frame: up to 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 May 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcat based personal diet and Standard balanced diet in people with IBS - Irritable Bowel Syndrome, run by Sheba Medical Center at 1 site in Israel.
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 7 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 May 2023. 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 Israel. 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?
Irritable Bowel Syndrome (IBS) Symptom Severity Scale questionnaire (time frame: 8 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 May 2023.