Irritable Bowel SyndromeNCT03174561
Inuline Supplement in Patients With Irritable Bowel Syndrome
A study testing Inuline, Choline and Silymarin and diet restriction in people with Irritable Bowel Syndrome, run by SC Fiterman Pharma SRL at 1 site in Romania.
Trial summary
The study investigate the efficacy of the combination inuline, choline and silymarin in alleviating the symptomatology of the patients with irritable bowel syndrome with constipation in a randomized, cross-over, no treatment controlled study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Inuline, Choline and Silymarin and diet restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- 1 May 2017to 30 Apr 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years, diagnosed with Irritable Bowel Syndrome using Roma IV criteria
Who cannot join
- Patients with IBS with predominant diarrhea or mixt symptoms
- Patients with known hypersensitivity to any of the ingredients of the dietary supplement
- Patients who used prebiotic, probiotic or laxative products in the last 10 days
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon"
Iași
Vasile L Drug, Lecturer, vasidrug@email.com
About this study
Official title: Clinical Assessment of the Benefits of the Combination Inuline, Choline and Silymarin in Mitigating the Symptomatology in Patients With Irritable Bowel Syndrome
The study investigate the efficacy of the combination inuline, choline and silymarin in alleviating the symptomatology of the patients with irritable bowel syndrome with constipation in a randomized, cross-over, no treatment controlled study.
Read the detailed description
In this study patients diagnosed using Rome IV criteria with irritable bowel syndrome with constipation are included. The study was approved by the Ethic Committee of the University of Medicine and Pharmacy "Gr. T Popa" Iasi to be conducted at the Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi. The patients are assigned after a randomized scheme to one of the groups: diet restriction scheme or diet restriction scheme plus a product with inuline, choline and silymarin. After 28 days the patients are crossed between the groups and followed for additional 28 days diet scheme with or without inuline, choline and silymarin supplementation. All the patients are evaluated initially, in the day 28 and in the day 57 for the stool habits, stool characteristics using Brystol Scale and symptoms severity (abdominal pain, frequency of abdominal pain, bloating severity, patients satisfaction in relation with stool frequency and the impact of IBS on daily activity) as appreciated by the patients for the last 10 days.
The acquired data will be analyzed and published.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Inuline, Choline and Silymarin, diet restriction
- 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.
Inuline, Choline and SilymarinDietary supplement
Also called Stoptoxin plicuri
Combination of one sachet: Inuline (5000 mg), Silybum marianum seed extract (50 mg), Choline (37 mg) The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days. Diet restriction is consider together with dietary supplement intake.
diet restrictionOther
diet restriction for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Inuline, Choline and Silymarin + Diet | Other | Patients diagnosed with Irritable bowel syndrome who will follow diet restrictions together with a dietary supplement.
Intervention: Dietary Supplement, a combination of Inuline, Silymarin and Choline The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days Receives: Dietary Supplement: Inuline, Choline and Silymarin |
| Diet restriction | Other | Patients diagnosed with Irritable bowel syndrome who will follow diet restrictions for 28 days. After the first month the patients are crossed between groups. Receives: Other: diet restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS symptoms severity score
visual analogue scale for IBS symptoms severity will be used
Measured: the last 10 days
number of bowel movements
number of bowel movements/week
Measured: the last 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start1 May 2017
- Primary completion28 Feb 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SC Fiterman Pharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vasile L Drug, Lecturer, Principal investigator, Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" IasiIoan Chirila, Consultant, Study chair, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174561
- Sponsor's protocol ID
- STCL009
- Status last verified
- May 2017
- First submitted
- 31 May 2017
- Last updated
- 2 Jun 2017
- 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 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Benefits of the Combination Inuline, Choline and Silymarin in Mitigating the Symptomatology in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03174561
- Acronym / sponsor ID
- STCL009
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SC Fiterman Pharma SRLIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 2 Jun 2017 (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.
The study investigate the efficacy of the combination inuline, choline and silymarin in alleviating the symptomatology of the patients with irritable bowel syndrome with constipation in a randomized, cross-over, no treatment controlled study.
Detailed description
In this study patients diagnosed using Rome IV criteria with irritable bowel syndrome with constipation are included. The study was approved by the Ethic Committee of the University of Medicine and Pharmacy "Gr. T Popa" Iasi to be conducted at the Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi. The patients are assigned after a randomized scheme to one of the groups: diet restriction scheme or diet restriction scheme plus a product with inuline, choline and silymarin. After 28 days the patients are crossed between the groups and followed for additional 28 days diet scheme with or without inuline, choline and silymarin supplementation. All the patients are evaluated initially, in the day 28 and in the day 57 for the stool habits, stool characteristics using Brystol Scale and symptoms severity (abdominal pain, frequency of abdominal pain, bloating severity, patients satisfaction in relation with stool frequency and the impact of IBS on daily activity) as appreciated by the patients for the last 10 days.
The acquired data will be analyzed and published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inuline, Choline and Silymarin + Diet | Other | Dietary Supplement: Inuline, Choline and SilymarinPatients diagnosed with Irritable bowel syndrome who will follow diet restrictions together with a dietary supplement. Intervention: Dietary Supplement, a combination of Inuline, Silymarin and Choline The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days |
| Diet restriction | Other | Other: diet restrictionPatients diagnosed with Irritable bowel syndrome who will follow diet restrictions for 28 days. After the first month the patients are crossed between groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-75 years, diagnosed with Irritable Bowel Syndrome using Roma IV criteria
Key exclusion criteria (4 listed)
- Patients with IBS with predominant diarrhea or mixt symptoms
- Patients with known hypersensitivity to any of the ingredients of the dietary supplement
- Patients who used prebiotic, probiotic or laxative products in the last 10 days
- Pregnancy and lactation
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 |
|---|---|---|
| Inuline, Choline and SilymarinAlso: Stoptoxin plicuriCombination of one sachet: Inuline (5000 mg), Silybum marianum seed extract (50 mg), Choline (37 mg) The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days. Diet restriction is consider together with dietary supplement intake. | Dietary supplement | Inuline, Choline and Silymarin + Diet |
| diet restrictiondiet restriction for 28 days | Other | Diet restriction |
Primary outcome
IBS symptoms severity score
Time frame: the last 10 days
visual analogue scale for IBS symptoms severity will be used
number of bowel movements
Time frame: the last 7 days
number of bowel movements/week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- 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.
Vasile L Drug, Lecturer principal investigator
Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi
Ioan Chirila, Consultant study chair
National Institute of public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inuline, Choline and Silymarin and diet restriction in people with Irritable Bowel Syndrome, run by SC Fiterman Pharma SRL at 1 site in Romania.
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 1 inclusion and 4 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 2 Jun 2017. 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 Romania. 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. 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 Vasile L Drug, Lecturer (+40745589065, vasidrug@email.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS symptoms severity score (time frame: the last 10 days). 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 2 Jun 2017.