IBS - Irritable Bowel SyndromeNCT05565612
Clinical Trial to Evaluate the Effect of a Probiotic Mixture on Signs and Symptoms of Irritable Bowel Syndrome
A study testing Normodigest Classic in people with IBS - Irritable Bowel Syndrome, run by Laboratorio Industrial de Herbodietetica Aplicada S.L at 1 site in Spain.
Trial summary
The clinical trial has a randomized, double-blind and placebo-controlled design, in which the effect of a probiotic mix wants to be evaluated, with a treatment of 12 weeks, in the evolution of the symptoms of Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Normodigest Classic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2022to 1 Mar 2024
- 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
- Aged between 18-65 years old.
- Informed consent signed by the patient.
- Patients with Irritable Bowel Syndrome diagnosed by Roma IV criteria
Who cannot join
- Patients who took antibiotics until two weeks prior to study.
- Patients who have taken other probiotics two months prior.
- Patients with other intestinal inflammatory diseases.
- Pregnant, breastfeeding or patients who do not compromise to use an efficient contraceptive method during the development of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture on Signs and Symptoms of Irritable Bowel Syndrome
The clinical trial has a randomized, double-blind and placebo-controlled design, in which the effect of a probiotic mix wants to be evaluated, with a treatment of 12 weeks, in the evolution of the symptoms of Irritable Bowel Syndrome.
The 12 weeks of the treatment are structured in four in-person visits: Visit 1 (initial; week 0), Visit 2 (halfway; week 4), Visit 3 (halfway; week 8) and Visit 4 (final; week 12).
Read the detailed description
Below, the four visits that compose the study and what to do in each one of them are described:
Visit 1 or initial (Week 0)
With the aim of recruiting patients, all patients diagnosed with irritable bowel who go to a consultation in the participant centres shall be informed of the study. If the patient shows interest, they shall be given detailed information about the study and the implications of their participation so that they can sign the informed consent if they wish so. Before signing, the patients shall have enough time to read and consider the detailed information and ask the investigator. The process of recruitment of patients shall continue until the sample size is reached.
Once the informed consent is signed, a doctor trained for the study shall make the initial interview in which the patient is tested to meet all the criterion for inclusion and none for exclusion (see clause 5.3.) and their clinical history.
The investigator shall proceed to assign to the patient the participant number on the study and, according to a previously elaborated randomization list, they shall be assigned the treatment that they shall receive during the study.
Once gotten to this point, the investigator shall value the severity and the symptoms of the Irritable Bowel Syndrome, by means of the IBS-SSS and IBS-QOL questionnaires (Annex I and II).
The patient shall be given the treatment with the assigned code, enough for the next programmed visit.
They shall be asked to turn in a stool sample and the nurse staff shall take a blood sample.
Visit 2 (Week 4) and visit 3 (Week 8)
In the halfway visits, in addition to value the symptoms of the disease with the scales detailed on the variable clause, the investigator shall register the adverse occurrences reported by the patient in a Case Report Form (CRF), as well as the concomitant treatments used.
Furthermore, the compliance rate of the treatment shall be calculated through the counting of the vials given back by the patient.
The patient shall be given new treatment, with the same code, enough until the next visit.
Visit 4 (Week 12)
In this visit the symptoms of the disease shall be valued with the two scales used in the study and the treatments that the patient has required during the 12 weeks following the end of the treatment under consideration.
Same as the first visit, they shall be asked to turn in a stool sample and they shall be taken a blood sample.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Normodigest Classic, Placebo
- 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.
Normodigest ClassicDietary supplement
Symbiotic composed of 15 probiotic strains and fructooligosaccharides as prebiotic
PlaceboDietary supplement
Compound based on maltodextrin and other excipients
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Normodigest Classic
Multi-strain probiotic mixture (15 strains) with a concentration of 7,5 x 10^9 + fructooligosaccharides
1 vial of 10 ml per day for 12 weeks Receives: Dietary Supplement: Normodigest Classic |
| Placebo group | Placebo comparator | Maltodextrin-based placebo
1 vial of 10 ml per day for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on IBS-SSS (Irritable Bowel Syndrome-Severity Scoring System) scale at 4, 8 and 12 weeks
IBS index measures the severity of the disease, wich takes into account aspects such as pain, abdominal distension, intestinal habit and quality of life of the patient with IBS
Categories of severity according to punctuation on the index IBS-SSS
- Mild: 75 <175
- Moderate: 175 <300
- Severe: > 300
Measured: 12 weeks
Secondary outcomes (14)
Change from baseline on IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index at 4, 8 and 12 weeks
IBS-QoL measures the impact of the disease on the quality of life of patients with IBS
The questionnaire consists of 34 questions with a score of 1 to 5 in each of them.
Measured: 12 weeks
Change from baseline on values of hemogram to final visit
Complete blood count
Measured: 12 weeks
Change from baseline on values of blood glucose to final visit
Blood glucose parameters (mg/dL)
Measured: 12 weeks
Change from baseline on values of blood sodium to final visit
Blood sodium parameters (mEq/L)
Measured: 12 weeks
Change from baseline on values of blood potassium to final visit
Blood potassium parameters (mEq/L)
Measured: 12 weeks
Change from baseline on values of blood chlorine to final visit
Blood chlorine parameters (mEq/L)
Measured: 12 weeks
Change from baseline on values of blood creatinine to final visit
Blood creatinine parameters (mg/dL)
Measured: 12 weeks
Change from baseline on values of blood HDL, LDL and total cholesterol to final visit
Blood HDL, LDL an total cholesterol parameters (mg/dL)
Measured: 12 weeks
Change from baseline on values of blood triglycerides to final visit
Blood triglycerides parameters (mg/dL)
Measured: 12 weeks
Change from baseline on values of blood C-reactive protein to final visit
Blood C-reactive protein parameters (mg/L)
Measured: 12 weeks
Change from baseline on values of blood gamma glutamyl transferase (GGT) to final visit
Blood GGT parameters (mg/L)
Measured: 12 weeks
Change from baseline on values of blood glutamic pyruvic transaminase (GPT) to final visit
Blood GPT parameters (mg/L)
Measured: 12 weeks
Gut microbiota changes from baseline to final visit
Alpha Diversity, Beta Diversity, and Composition, Using R16s Gene Sequencing of a Stool Sample
Measured: 12 weeks
Compliance rate at 4, 8 and 12 12 weeks
Assess compliance rate at each visit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start10 Oct 2022
- Primary completion26 Dec 2023
- Study completion1 Mar 2024
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.
- 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
- Pilot randomized, double-blind, placebo-controlled study of a duration of 12 weeks
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Industrial de Herbodietetica Aplicada S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicente Navarro López, PhD; MD, Principal investigator, Universidad Católica San Antonio de Murcia (UCAM). MiBioPath Group.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565612
- Sponsor's protocol ID
- SII.PROB
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture on Signs and Symptoms of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05565612
- Acronym / sponsor ID
- SII.PROB
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Laboratorio Industrial de Herbodietetica Aplicada S.LIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 4 Oct 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.
The clinical trial has a randomized, double-blind and placebo-controlled design, in which the effect of a probiotic mix wants to be evaluated, with a treatment of 12 weeks, in the evolution of the symptoms of Irritable Bowel Syndrome.
The 12 weeks of the treatment are structured in four in-person visits: Visit 1 (initial; week 0), Visit 2 (halfway; week 4), Visit 3 (halfway; week 8) and Visit 4 (final; week 12).
Detailed description
Below, the four visits that compose the study and what to do in each one of them are described:
Visit 1 or initial (Week 0)
With the aim of recruiting patients, all patients diagnosed with irritable bowel who go to a consultation in the participant centres shall be informed of the study. If the patient shows interest, they shall be given detailed information about the study and the implications of their participation so that they can sign the informed consent if they wish so. Before signing, the patients shall have enough time to read and consider the detailed information and ask the investigator. The process of recruitment of patients shall continue until the sample size is reached.
Once the informed consent is signed, a doctor trained for the study shall make the initial interview in which the patient is tested to meet all the criterion for inclusion and none for exclusion (see clause 5.3.) and their clinical history.
The investigator shall proceed to assign to the patient the participant number on the study and, according to a previously elaborated randomization list, they shall be assigned the treatment that they shall receive during the study.
Once gotten to this point, the investigator shall value the severity and the symptoms of the Irritable Bowel Syndrome, by means of the IBS-SSS and IBS-QOL questionnaires (Annex I and II).
The patient shall be given the treatment with the assigned code, enough for the next programmed visit.
They shall be asked to turn in a stool sample and the nurse staff shall take a blood sample.
Visit 2 (Week 4) and visit 3 (Week 8)
In the halfway visits, in addition to value the symptoms of the disease with the scales detailed on the variable clause, the investigator shall register the adverse occurrences reported by the patient in a Case Report Form (CRF), as well as the concomitant treatments used.
Furthermore, the compliance rate of the treatment shall be calculated through the counting of the vials given back by the patient.
The patient shall be given new treatment, with the same code, enough until the next visit.
Visit 4 (Week 12)
In this visit the symptoms of the disease shall be valued with the two scales used in the study and the treatments that the patient has required during the 12 weeks following the end of the treatment under consideration.
Same as the first visit, they shall be asked to turn in a stool sample and they shall be taken a blood sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Pilot randomized, double-blind, placebo-controlled study of a duration of 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Normodigest ClassicNormodigest Classic Multi-strain probiotic mixture (15 strains) with a concentration of 7,5 x 10^9 + fructooligosaccharides 1 vial of 10 ml per day for 12 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin-based placebo 1 vial of 10 ml per day for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18-65 years old.
- Informed consent signed by the patient.
- Patients with Irritable Bowel Syndrome diagnosed by Roma IV criteria
Key exclusion criteria (4 listed)
- Patients who took antibiotics until two weeks prior to study.
- Patients who have taken other probiotics two months prior.
- Patients with other intestinal inflammatory diseases.
- Pregnant, breastfeeding or patients who do not compromise to use an efficient contraceptive method during the development of the study.
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 |
|---|---|---|
| Normodigest ClassicSymbiotic composed of 15 probiotic strains and fructooligosaccharides as prebiotic | Dietary supplement | Probiotic group |
| PlaceboCompound based on maltodextrin and other excipients | Dietary supplement | Placebo group |
Primary outcome
Change from baseline on IBS-SSS (Irritable Bowel Syndrome-Severity Scoring System) scale at 4, 8 and 12 weeks
Time frame: 12 weeks
IBS index measures the severity of the disease, wich takes into account aspects such as pain, abdominal distension, intestinal habit and quality of life of the patient with IBS Categories of severity according to punctuation on the index IBS-SSS * Mild: 75 <175 * Moderate: 175 <300 * Severe: > 300
14 secondary outcomes
Change from baseline on IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index at 4, 8 and 12 weeks
Time frame: 12 weeks
Change from baseline on values of hemogram to final visit
Time frame: 12 weeks
Change from baseline on values of blood glucose to final visit
Time frame: 12 weeks
Change from baseline on values of blood sodium to final visit
Time frame: 12 weeks
Change from baseline on values of blood potassium to final visit
Time frame: 12 weeks
Change from baseline on values of blood chlorine to final visit
Time frame: 12 weeks
Change from baseline on values of blood creatinine to final visit
Time frame: 12 weeks
Change from baseline on values of blood HDL, LDL and total cholesterol to final visit
Time frame: 12 weeks
Change from baseline on values of blood triglycerides to final visit
Time frame: 12 weeks
Change from baseline on values of blood C-reactive protein to final visit
Time frame: 12 weeks
Change from baseline on values of blood gamma glutamyl transferase (GGT) to final visit
Time frame: 12 weeks
Change from baseline on values of blood glutamic pyruvic transaminase (GPT) to final visit
Time frame: 12 weeks
Gut microbiota changes from baseline to final visit
Time frame: 12 weeks
Compliance rate at 4, 8 and 12 12 weeks
Time frame: 12 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 28 Mar 2024.
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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.
Vicente Navarro López, PhD; MD principal investigator
Universidad Católica San Antonio de Murcia (UCAM). MiBioPath Group.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normodigest Classic in people with IBS - Irritable Bowel Syndrome, run by Laboratorio Industrial de Herbodietetica Aplicada S.L at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 28 Mar 2024. 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 Spain. 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?
Change from baseline on IBS-SSS (Irritable Bowel Syndrome-Severity Scoring System) scale at 4, 8 and 12 weeks (time frame: 12 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 28 Mar 2024.