IBSPhase 4NCT01779765
The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome (IBS)
A Phase 4 study testing PHGG and Maltodextrin in people with IBS, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study objective is to assess the short and long term effects of partially hydrolyzed guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBS
- What is being tested?
- PHGG and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfillment of the Rome III criteria for IBS.
- Aged 20-68 years at the time of screening.
- Provision of written informed consent.
- Commitment of availability throughout the 6 months study period.
Who cannot join
- Major abdominal surgery in the past.
- The presence of any active (organic)GI disease.
- Past or present major medical or psychiatric illness.
- Any concomitant disease.
- Alarming symptoms (rectal bleeding, weight loss, etc.)
- Pregnancy.
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- Family history of colorectal carcinoma or inflammatory bowel disease (IBD).
- Abnormal laboratory studies (blood biochemistry , liver enzymes,complete blood count), abnormal thyroid function.
- Non-adjusted diet in the case of lactose or gluten intolerance.
- Recent travel to regions with endemic parasitic diseases.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Nachum Vaisman, MD, 972-3-6974807, vaisman@tasmc.health.gov.il
About this study
Official title: The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome- a Double Blind, Placebo - Controlled, Randomized Study
This study objective is to assess the short and long term effects of partially hydrolyzed guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these patients.
- Conditions
- IBS
- Being tested
- PHGG, Maltodextrin
- Keywords
- IBS, Diarrhea, Constipation, Fibers
- Medical subject headings
- Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHGGDietary supplement
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| PHGG | Experimental | 2.5gr per day for the first week and then 5gr per day for 11 weeks. Receives: Dietary Supplement: PHGG |
| Maltodextrin | Placebo comparator | 2.5gr per day for the first week and then 5gr per day for 11 weeks. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in IBS score.
IBS scoring - Francis severity IBS score.
Measured: 2 years
Secondary outcomes (1)
Quality questionnaire
Quality of life - by the IBS - quality of life questionnaire - Drossman Patrick.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IBSStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779765
- Sponsor's protocol ID
- TASMC-12-NV-242-CTIL
- Status last verified
- Jan 2013
- First submitted
- 10 Jan 2013
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones J, Boorman J, Cann P, Forbes A, Gomborone J, Heaton K, Hungin P, Kumar D, Libby G, Spiller R, Read N, Silk D, Whorwell P. British Society of Gastroenterology guidelines for the management of the irritable bowel syndrome. Gut. 2000 Nov;47 Suppl 2(Suppl 2):ii1-19. doi: 10.1136/gut.47.suppl_2.ii1. No abstract available.
PubMed 11053260Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. doi: 10.1056/NEJMra035579. No abstract available.
PubMed 14645642Parisi GC, Zilli M, Miani MP, Carrara M, Bottona E, Verdianelli G, Battaglia G, Desideri S, Faedo A, Marzolino C, Tonon A, Ermani M, Leandro G. High-fiber diet supplementation in patients with irritable bowel syndrome (IBS): a multicenter, randomized, open trial comparison between wheat bran diet and partially hydrolyzed guar gum (PHGG). Dig Dis Sci. 2002 Aug;47(8):1697-704. doi: 10.1023/a:1016419906546.
PubMed 12184518Niv E, Halak A, Tiommny E, Yanai H, Strul H, Naftali T, Vaisman N. Randomized clinical study: Partially hydrolyzed guar gum (PHGG) versus placebo in the treatment of patients with irritable bowel syndrome. Nutr Metab (Lond). 2016 Feb 6;13:10. doi: 10.1186/s12986-016-0070-5. eCollection 2016.
PubMed 26855665
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hydrolyzed Guar Gum ( PHGG) in the Treatment of Patients With Irritable Bowel Syndrome- a Double Blind, Placebo - Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT01779765
- Acronym / sponsor ID
- TASMC-12-NV-242-CTIL
- Conditions
- IBS
- Keywords
- IBS, Diarrhea, Constipation, Fibers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 30 Jan 2013 (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.
This study objective is to assess the short and long term effects of partially hydrolyzed guar gum (PHGG) administration on clinical symptoms of IBS and quality of life of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHGG | Experimental | Dietary Supplement: PHGG2.5gr per day for the first week and then 5gr per day for 11 weeks. |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin2.5gr per day for the first week and then 5gr per day for 11 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fulfillment of the Rome III criteria for IBS.
- Aged 20-68 years at the time of screening.
- Provision of written informed consent.
- Commitment of availability throughout the 6 months study period.
Key exclusion criteria (10 listed)
- Major abdominal surgery in the past.
- The presence of any active (organic)GI disease.
- Past or present major medical or psychiatric illness.
- Any concomitant disease.
- Alarming symptoms (rectal bleeding, weight loss, etc.)
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 |
|---|---|---|
| PHGG | Dietary supplement | PHGG |
| Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
Improvement in IBS score.
Time frame: 2 years
IBS scoring - Francis severity IBS score.
1 secondary outcome
Quality questionnaire
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Background: PubMed 11053260Jones J, Boorman J, Cann P, Forbes A, Gomborone J, Heaton K, Hungin P, Kumar D, Libby G, Spiller R, Read N, Silk D, Whorwell P. British Society of Gastroenterology guidelines for the management of the irritable bowel syndrome. Gut. 2000 Nov;47 Suppl 2(Suppl 2):ii1-19. doi: 10.1136/gut.47.suppl_2.ii1. No abstract available.
- Background: PubMed 14645642Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. doi: 10.1056/NEJMra035579. No abstract available.
- Background: PubMed 12184518Parisi GC, Zilli M, Miani MP, Carrara M, Bottona E, Verdianelli G, Battaglia G, Desideri S, Faedo A, Marzolino C, Tonon A, Ermani M, Leandro G. High-fiber diet supplementation in patients with irritable bowel syndrome (IBS): a multicenter, randomized, open trial comparison between wheat bran diet and partially hydrolyzed guar gum (PHGG). Dig Dis Sci. 2002 Aug;47(8):1697-704. doi: 10.1023/a:1016419906546.
- Derived from this study: PubMed 26855665Niv E, Halak A, Tiommny E, Yanai H, Strul H, Naftali T, Vaisman N. Randomized clinical study: Partially hydrolyzed guar gum (PHGG) versus placebo in the treatment of patients with irritable bowel syndrome. Nutr Metab (Lond). 2016 Feb 6;13:10. doi: 10.1186/s12986-016-0070-5. eCollection 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PHGG and Maltodextrin in people with IBS, run by Tel-Aviv Sourasky 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 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: status not confirmed, as of the sponsor's last update on 27 Mar 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nachum Vaisman, MD (972-3-6974807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in IBS score. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779765, which also lists 4 linked publications.
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 27 Mar 2014.