Irritable Bowel SyndromeMOSAICNCT01252550
Effects of Activia in IBS
A study testing Activia® (125g/pot) and Acidified non-fermented dairy product in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 3 sites in Sweden.
Trial summary
The purpose of this study is to investigate the association between gut microbiota, immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge test in IBS patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Activia® (125g/pot) and Acidified non-fermented dairy product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesSweden
- Study dates
- May 2010to Aug 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Age: between 18 and 65 years old at baseline visit
- IBS according to the Rome III criteria
- Ability to understand and willingness to comply to the study procedures
Who cannot join
- Participation in another clinical study 1 month prior to screening visit and throughout the study
- Abnormal results on the screening laboratory tests clinically relevant for study participation
- Other gastrointestinal disease(s) explaining the patient's symptoms, as judged by the investigator
- Other severe disease(s) such as malignancy, severe heart disease, kidney disease or neurological disease
- Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, weight loss or fever
- Severe psychiatric disease
Show all 12Show fewer
- Previous history of drug or alcohol abuse 6 months prior to screening
- Intolerance or allergy against milk products or gluten
- Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study
- Consumption of antibiotics 1 month prior to screening and throughout the study
- Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study
- Pregnant or lactating or wish to become pregnant during the period of the study
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41345
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, 41345
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, S413-45
About this study
Official title: Association Between GI Microbiota, Low-grade Inflammation and Classical Pathophysiological Factors in Patients With Irritable Bowel Syndrome (IBS) and Effect of the Consumption of Activia on GI Symptoms Provoked by a Lactulose Challenge Test in IBS Patients
The purpose of this study is to investigate the association between gut microbiota, immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge test in IBS patients.
Read the detailed description
BACKGROUND
There is a wide variety of symptoms in IBS, irritable bowel syndrome, both among individuals and in the symptoms of a specific individual. Pathophysiological factors that are of importance have been identified in IBS, but all of the factors do not occur in the symptomatology of all patients. Visceral hypersensitivity, deviant motor and secretion function in the gastrointestinal tract as well as psychological factors are believed to be of importance. However the relative importance of specific factors in the symptomatology is not elucidated.
Deviations in the autonomic and central nerve function have also been demonstrated in IBS, along with low grad inflammation, immunological anomalies, and changes in the microbiological gut flora. The importance of these factors in developing the more established pathophysiological factors, visceral hypersensitivity, and deviated gastrointestinal motor and secretion functions have not yet been studied. Neither have the interactions between the autonomic and central nerve functions or the significance of these functions in IBS.
In response to the recent findings, regarding deviant microbiological gut flora in IBS, the use of probiotics as treatment has been tested, with altering outcome. The effects of some products are positive, but far from all the patients with IBS get sufficient relief. The response of treatment with probiotics cannot be predicted with the methods available today; in example it is not possible to predict which patient will respond to the treatment and what the mechanisms behind the symptom relief are.
Questions
- What affects the symptomatology in IBS?
- Visceral hypersensitivity
- Deviant colonic motor function
- Autonomic nerve dysfunction
- Central nerve dysfunction (especially in the level of the brain stem)
- Psychological factors
- Coping
- Demography (sex, age)
- Immunological deviations in peripheral blood/intestine
- Deviations in the composition of the microbiological gut flora
- Sexual/physical abuse
- What are the interactions between pathophysiological deviations in IBS?
- Can the treatment response of probiotics be predicted?
- Why do probiotics give relief to some of the patients with IBS?
INVESTIGATION
- A structured investigational model, covering the most important pathophysiological factors in IBS and clarifying the symptomatology of the patients in detail.
- A randomized, double blinded placebo controlled study, evaluating the effects of probiotics (Bifidobacterium lactis) on the symptomatology in IBS as well as measuring the effect probiotics have on the fermentation in the intestines, immunological variables and the composition of the microbiological gut flora.
VISIT 1
- The patients are thoroughly informed regarding the context of the study and a written consent is signed.
- Blood samples are taken to rule out any organic disease (Hb, LPK, TPK, Na, K, Crea, Liver status, CRP, Transglutaminase antibodies).
- Validated questionnaires are completed
- IBS Symptom Severity Scale (IBS-SSS) - gastrointestinal and extra intestinal symptoms
- Gastrointestinal Symptom Rating Scale - IBS (GSRS-IBS) - IBS specific GI-symptoms
- Hospital Anxiety and Depression Scale (HAD) - general anxiety and depression
- Visceral Sensitivity Index (VSI) - GI-specific anxiety
- Patient Health Questionnaire-15 (PHQ-15) - severity of somatisation, depression, anxiety (panic anxiety, eating disorders and alcohol problems)
- IBS Quality of Life Questionnaire (IBSQOL) - disease specific health related quality of life
- Fatigue Impact Scale (FIS) - impact of fatigue on quality of life
- Abuse Questionnaire - physical and sexual abuse
- Sense of Coherence Index - sense of coherence, coping
- ABR (Auditory Brain stem Response audiometry) - brain stem audiometry measuring the electric activity in level of the brain stem while listening to different audio stimuli (listening to sounds of clicks through headphones). Through this test the function of the brain stem can be measured, its ability to mask the effect of disturbing noises etc.
- Holter-ECG (24 h) - spectrum analysis to evaluate the autonomic nerve function; the balance between parasympathetic and sympathetic nerve function.
- Permeability test of the intestine - the patient drinks a liquid solution of water and sugars (50.0 g sucrose, 5.0 g mannitol, 10.0 g lactulose and 1.0 g sucralose in 200 ml tap water), thereafter urine is collected during the following 9 h. The amount of sugars found in the urine is a measurement of the permeability in the intestines. The urine will be collected in separate containers depending on what time of the day it is, and depending on the time the permeability in the small intestine respectively in the large intestine can be measured separately.
- Registration of stool consistency and frequency over the following 2-3 weeks, until visit 3, using the "Bristol Stool Form Scale" (BSF)
- Food journal are handed out - food intake over three consecutive days will be registered by the patient.
VISIT 2
- Handing in urine - the last of the urine collected on visit 1 is being handed in by the patient.
- Returning EKG-material - the Holter, recording EKG, is returned by the patient.
VISIT 3
- Salivary sample - test to measure the levels of cortisol, an important stress marker.
- Oro-anal transit time - 60 markers that can be seen through x-ray examination are being swallowed prior to the visit (10 markers/day during 6 days) and in the examination it is possible to see how many of the markers remain in the GI-tract and where in the tract they are positioned. This is a way to measure the oro-anal transit time, which mainly is determined by the colonic transit time. Thereby this is an indirect measurement of the motor function in colon. Regional transit in different colonic parts can be assessed by evaluating where in the colon the markers are.
- Rectal sensitivity testing - a balloon is placed in the rectum and is through a tube attached to a so called barostat. By using the barostat it is possible to inflate and deflate the balloon in a controlled matter and also to measure compression and volume in the balloon. The compression and volume is being increased in a predetermined way and the patient is asked to state how it feels by using VAS-scales; symptoms noted and the intensity of these symptoms. The sensitivity in the rectum (large intestine) can be described by valuing the levels of compression and volume that give rise to the symptoms.
VISIT 4
- Sigmoidoscopy with biopsies. Macroscopic evaluation of the mucosa of the large intestine, to rule out inflammatory bowel disease as a cause of the patients symptoms. Biopsies from the rectum and sigmoid are collected to be analyzed in regards of inflammatory cell populations and interleukins in the colonic mucosa, as well as amount of bacteria in the mucosa. Molecular techniques will be used, such as 16sRNA.
- Stool sample - analysis of immunological and inflammatory markers in the faeces and of the composition of the microbiological bacterial flora, this reflects the luminal bacterial flora (16sRNA technique will be used).
- Blood samples - various immunological analysis, for example different pro- and anti-inflammatory interleukins and different food related antibodies (IgE, IgG), are done to evaluate toe immunological activity and propensity to react in an unfavorable way when for instance consuming certain food items.
- Symptom protocol (IBS-SSS) and journal of stool consistency and frequency (Bristol Stool Form Scale (BSF)) are handed out. Symptoms and stools will be registered during 1-3 weeks and will be used as basal values prior to the treatment period.
VISIT 5
- Lactulose challenge test - evaluation of symptoms and excretion of hydrogen and methane gas in the exhaled air after intake of a liquid meal (400ml Nutridrink®, 1.5 kcal/ml) containing 25 mg lactulose. Hydrogen and methane gas in the exhaled air is a measurement of the degree of fermentation in the intestines, and indirectly can a bacterial overgrowth in the small intestine be detected. This "challenge" test is more of a physiological test to study the sensitivity of the GI-tract. The symptoms and excretion of gas will be registered during 4 h.
- Stool sample - analysis of immunological and inflammatory markers in the faeces and of the composition of the microbiological bacterial flora, this reflects the luminal bacterial flora (16sRNA technique will be used).
- Salivary sample - test to measure the levels of cortisol, an important stress marker.
- Randomization of the patients as they are included in the treatment part of the study. The patients will during 14 days have a daily intake of a yoghurt containing probiotics (Bifidobacterium lactis, Activia®) or a yoghurt without probiotics (placebo), 125 g 2 times a day (morning and evening). During the treatment part the patients register symptoms (Symptom protocol (IBS-SSS)) and stool consistency and frequency (Bristol Stool Form Scale (BSF)).
VISIT 6
- Visit takes place on the last day of the treatment period.
- Lactulose challenge test is being repeated to evaluate potential differences in symptoms and excretion of hydrogen and methane gas in the exhaled air after intake of a liquid meal (400ml Nutridrink®, 1.5 kcal/ml) containing 25 mg lactulose.
- Stool sample - analysis of immunological and inflammatory markers in the faeces and of the composition of the microbiological bacterial flora, this reflects the luminal bacterial flora (16sRNA technique will be used).
- Blood samples - various immunological analysis, for example different pro- and anti-inflammatory interleukins and different food related antibodies (IgE, IgG), are done to evaluate toe immunological activity and propensity to react in an unfavorable way when for instance consuming certain food items. Will be compared with previous blood samples.
VISIT 7
- Summarizing visit - visit at a doctor specialized in functional GI-disorders. The results from the tests and analysis of the previous visits are being evaluated and any potential treatment is based on these results. The patients are offered a telephone based follow-up if they want to, otherwise they are recommitted to the primary health care.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Activia® (125g/pot), Acidified non-fermented dairy product
- Keywords
- IBS, GI, QOL, Pathophysiology, Gut microbiota, Danone, Activia, Probiotics
- 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.
Activia® (125g/pot)Dietary supplement
Activia® (125g/pot) - dairy product containing bacterial culture Acti Regularis®
Acidified non-fermented dairy productDietary supplement
Acidified non-fermented dairy product (125g/pot)
| Study group | Role | What they receive |
|---|---|---|
| Activia® | Active comparator | Activia® (125g/pot) Receives: Dietary Supplement: Activia® (125g/pot) |
| Acidified non-fermented dairy product | Placebo comparator | Acidified non-fermented dairy product (125g/pot) Receives: Dietary Supplement: Acidified non-fermented dairy product |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS symptoms
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, Magnus Simrén, Sahlgrenska University Hospital
- Investigators
- Magnus Simrén, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252550
- Sponsor's protocol ID
- NU341
- Acronym
- MOSAIC
- Status last verified
- Nov 2014
- First submitted
- 2 Dec 2010
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tap J, Storsrud S, Le Neve B, Cotillard A, Pons N, Dore J, Ohman L, Tornblom H, Derrien M, Simren M. Diet and gut microbiome interactions of relevance for symptoms in irritable bowel syndrome. Microbiome. 2021 Mar 26;9(1):74. doi: 10.1186/s40168-021-01018-9.
PubMed 33771219Le Neve B, Derrien M, Tap J, Brazeilles R, Cools Portier S, Guyonnet D, Ohman L, Storsrud S, Tornblom H, Simren M. Fasting breath H2 and gut microbiota metabolic potential are associated with the response to a fermented milk product in irritable bowel syndrome. PLoS One. 2019 Apr 4;14(4):e0214273. doi: 10.1371/journal.pone.0214273. eCollection 2019.
PubMed 30946757Nybacka S, Storsrud S, Liljebo T, Le Neve B, Tornblom H, Simren M, Winkvist A. Within- and Between-Subject Variation in Dietary Intake of Fermentable Oligo-, Di-, Monosaccharides, and Polyols Among Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2018 Dec 24;3(2):nzy101. doi: 10.1093/cdn/nzy101. eCollection 2019 Feb.
PubMed 30838348Pohl D, Van Oudenhove L, Tornblom H, Le Neve B, Tack J, Simren M. Functional Dyspepsia and Severity of Psychologic Symptoms Associate With Postprandial Symptoms in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1745-1753.e1. doi: 10.1016/j.cgh.2018.04.034. Epub 2018 Apr 24.
PubMed 29702295Tap J, Derrien M, Tornblom H, Brazeilles R, Cools-Portier S, Dore J, Storsrud S, Le Neve B, Ohman L, Simren M. Identification of an Intestinal Microbiota Signature Associated With Severity of Irritable Bowel Syndrome. Gastroenterology. 2017 Jan;152(1):111-123.e8. doi: 10.1053/j.gastro.2016.09.049. Epub 2016 Oct 7.
PubMed 27725146Le Neve B, Brazeilles R, Derrien M, Tap J, Guyonnet D, Ohman L, Tornblom H, Simren M. Lactulose Challenge Determines Visceral Sensitivity and Severity of Symptoms in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2016 Feb;14(2):226-33.e1-3. doi: 10.1016/j.cgh.2015.09.039. Epub 2015 Oct 20.
PubMed 26492847
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between GI Microbiota, Low-grade Inflammation and Classical Pathophysiological Factors in Patients With Irritable Bowel Syndrome (IBS) and Effect of the Consumption of Activia on GI Symptoms Provoked by a Lactulose Challenge Test in IBS Patients
- ClinicalTrials.gov ID
- NCT01252550
- Acronym / sponsor ID
- MOSAIC / NU341
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, GI, QOL, Pathophysiology, Gut microbiota, Danone, Activia, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- May 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Dec 2010 (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.
The purpose of this study is to investigate the association between gut microbiota, immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge test in IBS patients.
Detailed description
BACKGROUND
There is a wide variety of symptoms in IBS, irritable bowel syndrome, both among individuals and in the symptoms of a specific individual. Pathophysiological factors that are of importance have been identified in IBS, but all of the factors do not occur in the symptomatology of all patients. Visceral hypersensitivity, deviant motor and secretion function in the gastrointestinal tract as well as psychological factors are believed to be of importance. However the relative importance of specific factors in the symptomatology is not elucidated.
Deviations in the autonomic and central nerve function have also been demonstrated in IBS, along with low grad inflammation, immunological anomalies, and changes in the microbiological gut flora. The importance of these factors in developing the more established pathophysiological factors, visceral hypersensitivity, and deviated gastrointestinal motor and secretion functions have not yet been studied. Neither have the interactions between the autonomic and central nerve functions or the significance of these functions in IBS.
In response to the recent findings, regarding deviant microbiological gut flora in IBS, the use of probiotics as treatment has been tested, with altering outcome. The effects of some products are positive, but far from all the patients with IBS get sufficient relief. The response of treatment with probiotics cannot be predicted with the methods available today; in example it is not possible to predict which patient will respond to the treatment and what the mechanisms behind the symptom relief are.
Questions
- What affects the symptomatology in IBS?
- Visceral hypersensitivity
- Deviant colonic motor function
- Autonomic nerve dysfunction
- Central nerve dysfunction (especially in the level of the brain stem)
- Psychological factors
- Coping
- Demography (sex, age)
- Immunological deviations in peripheral blood/intestine
- Deviations in the composition of the microbiological gut flora
- Sexual/physical abuse
- What are the interactions between pathophysiological deviations in IBS?
- Can the treatment response of probiotics be predicted?
- Why do probiotics give relief to some of the patients with IBS?
INVESTIGATION
- A structured investigational model, covering the most important pathophysiological factors in IBS and clarifying the symptomatology of the patients in detail.
- A randomized, double blinded placebo controlled study, evaluating the effects of probiotics (Bifidobacterium lactis) on the symptomatology in IBS as well as measuring the effect probiotics have on the fermentation in the intestines, immunological variables and the composition of the microbiological gut flora.
VISIT 1
- The patients are thoroughly informed regarding the context of the study and a written consent is signed.
- Blood samples are taken to rule out any organic disease (Hb, LPK, TPK, Na, K, Crea, Liver status, CRP, Transglutaminase antibodies).
- Validated questionnaires are completed
- IBS Symptom Severity Scale (IBS-SSS) - gastrointestinal and extra intestinal symptoms
- Gastrointestinal Symptom Rating Scale - IBS (GSRS-IBS) - IBS specific GI-symptoms
- Hospital Anxiety and Depression Scale (HAD) - general anxiety and depression
- Visceral Sensitivity Index (VSI) - GI-specific anxiety
- Patient Health Questionnaire-15 (PHQ-15) - severity of somatisation, depression, anxiety (panic anxiety, eating disorders and alcohol problems)
- IBS Quality of Life Questionnaire (IBSQOL) - disease specific health related quality of life
- Fatigue Impact Scale (FIS) - impact of fatigue on quality of life
- Abuse Questionnaire - physical and sexual abuse
- Sense of Coherence Index - sense of coherence, coping
- ABR (Auditory Brain stem Response audiometry) - brain stem audiometry measuring the electric activity in level of the brain stem while listening to different audio stimuli (listening to sounds of clicks through headphones). Through this test the function of the brain stem can be measured, its ability to mask the effect of disturbing noises etc.
- Holter-ECG (24 h) - spectrum analysis to evaluate the autonomic nerve function; the balance between parasympathetic and sympathetic nerve function.
- Permeability test of the intestine - the patient drinks a liquid solution of water and sugars (50.0 g sucrose, 5.0 g mannitol, 10.0 g lactulose and 1.0 g sucralose in 200 ml tap water), thereafter urine is collected during the following 9 h. The amount of sugars found in the urine is a measurement of the permeability in the intestines. The urine will be collected in separate containers depending on what time of the day it is, and depending on the time the permeability in the small intestine respectively in the large intestine can be measured separately.
- Registration of stool consistency and frequency over the following 2-3 weeks, until visit 3, using the "Bristol Stool Form Scale" (BSF)
- Food journal are handed out - food intake over three consecutive days will be registered by the patient.
VISIT 2
- Handing in urine - the last of the urine collected on visit 1 is being handed in by the patient.
- Returning EKG-material - the Holter, recording EKG, is returned by the patient.
VISIT 3
- Salivary sample - test to measure the levels of cortisol, an important stress marker.
- Oro-anal transit time - 60 markers that can be seen through x-ray examination are being swallowed prior to the visit (10 markers/day during 6 days) and in the examination it is possible to see how many of the markers remain in the GI-tract and where in the tract they are positioned. This is a way to measure the oro-anal transit time, which mainly is determined by the colonic transit time. Thereby this is an indirect measurement of the motor function in colon. Regional transit in different colonic parts can be assessed by evaluating where in the colon the markers are.
- Rectal sensitivity testing - a balloon is placed in the rectum and is through a tube attached to a so called barostat. By using the barostat it is possible to inflate and deflate the balloon in a controlled matter and also to measure compression and volume in the balloon. The compression and volume is being increased in a predetermined way and the patient is asked to state how it feels by using VAS-scales; symptoms noted and the intensity of these symptoms. The sensitivity in the rectum (large intestine) can be described by valuing the levels of compression and volume that give rise to the symptoms.
VISIT 4
- Sigmoidoscopy with biopsies. Macroscopic evaluation of the mucosa of the large intestine, to rule out inflammatory bowel disease as a cause of the patients symptoms. Biopsies from the rectum and sigmoid are collected to be analyzed in regards of inflammatory cell populations and interleukins in the colonic mucosa, as well as amount of bacteria in the mucosa. Molecular techniques will be used, such as 16sRNA.
- Stool sample - analysis of immunological and inflammatory markers in the faeces and of the composition of the microbiological bacterial flora, this reflects the luminal bacterial flora (16sRNA technique will be used).
- Blood samples - various immunological analysis, for example different pro- and anti-inflammatory interleukins and different food related antibodies (IgE, IgG), are done to evaluate toe immunological activity and propensity to react in an unfavorable way when for instance consuming certain food items.
- Symptom protocol (IBS-SSS) and journal of stool consistency and frequency (Bristol Stool Form Scale (BSF)) are handed out. Symptoms and stools will be registered during 1-3 weeks and will be used as basal values prior to the treatment period.
VISIT 5
- Lactulose challenge test - evaluation of symptoms and excretion of hydrogen and methane gas in the exhaled air after intake of a liquid meal (400ml Nutridrink®, 1.5 kcal/ml) containing 25 mg lactulose. Hydrogen and methane gas in the exhaled air is a measurement of the degree of fermentation in the intestines, and indirectly can a bacterial overgrowth in the small intestine be detected. This "challenge" test is more of a physiological test to study the sensitivity of the GI-tract. The symptoms and excretion of gas will be registered during 4 h.
- Stool sample - analysis of immunological and inflammatory markers in the faeces and of the composition of the microbiological bacterial flora, this reflects the luminal bacterial flora (16sRNA technique will be used).
- Salivary sample - test to measure the levels of cortisol, an important stress marker.
- Randomization of the patients as they are included in the treatment part of the study. The patients will during 14 days have a daily intake of a yoghurt containing probiotics (Bifidobacterium lactis, Activia®) or a yoghurt without probiotics (placebo), 125 g 2 times a day (morning and evening). During the treatment part the patients register symptoms (Symptom protocol (IBS-SSS)) and stool consistency and frequency (Bristol Stool Form Scale (BSF)).
VISIT 6
- Visit takes place on the last day of the treatment period.
- Lactulose challenge test is being repeated to evaluate potential differences in symptoms and excretion of hydrogen and methane gas in the exhaled air after intake of a liquid meal (400ml Nutridrink®, 1.5 kcal/ml) containing 25 mg lactulose.
- Stool sample - analysis of immunological and inflammatory markers in the faeces and of the composition of the microbiological bacterial flora, this reflects the luminal bacterial flora (16sRNA technique will be used).
- Blood samples - various immunological analysis, for example different pro- and anti-inflammatory interleukins and different food related antibodies (IgE, IgG), are done to evaluate toe immunological activity and propensity to react in an unfavorable way when for instance consuming certain food items. Will be compared with previous blood samples.
VISIT 7
- Summarizing visit - visit at a doctor specialized in functional GI-disorders. The results from the tests and analysis of the previous visits are being evaluated and any potential treatment is based on these results. The patients are offered a telephone based follow-up if they want to, otherwise they are recommitted to the primary health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activia® | Active comparator | Dietary Supplement: Activia® (125g/pot)Activia® (125g/pot) |
| Acidified non-fermented dairy product | Placebo comparator | Dietary Supplement: Acidified non-fermented dairy productAcidified non-fermented dairy product (125g/pot) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent
- Age: between 18 and 65 years old at baseline visit
- IBS according to the Rome III criteria
- Ability to understand and willingness to comply to the study procedures
Key exclusion criteria (12 listed)
- Participation in another clinical study 1 month prior to screening visit and throughout the study
- Abnormal results on the screening laboratory tests clinically relevant for study participation
- Other gastrointestinal disease(s) explaining the patient's symptoms, as judged by the investigator
- Other severe disease(s) such as malignancy, severe heart disease, kidney disease or neurological disease
- Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, weight loss or fever
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 |
|---|---|---|
| Activia® (125g/pot)Activia® (125g/pot) - dairy product containing bacterial culture Acti Regularis® | Dietary supplement | Activia® |
| Acidified non-fermented dairy productAcidified non-fermented dairy product (125g/pot) | Dietary supplement | Acidified non-fermented dairy product |
Primary outcome
IBS symptoms
Time frame: 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 18 Nov 2014.
- Derived from this study: PubMed 33771219Tap J, Storsrud S, Le Neve B, Cotillard A, Pons N, Dore J, Ohman L, Tornblom H, Derrien M, Simren M. Diet and gut microbiome interactions of relevance for symptoms in irritable bowel syndrome. Microbiome. 2021 Mar 26;9(1):74. doi: 10.1186/s40168-021-01018-9.
- Derived from this study: PubMed 30946757Le Neve B, Derrien M, Tap J, Brazeilles R, Cools Portier S, Guyonnet D, Ohman L, Storsrud S, Tornblom H, Simren M. Fasting breath H2 and gut microbiota metabolic potential are associated with the response to a fermented milk product in irritable bowel syndrome. PLoS One. 2019 Apr 4;14(4):e0214273. doi: 10.1371/journal.pone.0214273. eCollection 2019.
- Derived from this study: PubMed 30838348Nybacka S, Storsrud S, Liljebo T, Le Neve B, Tornblom H, Simren M, Winkvist A. Within- and Between-Subject Variation in Dietary Intake of Fermentable Oligo-, Di-, Monosaccharides, and Polyols Among Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2018 Dec 24;3(2):nzy101. doi: 10.1093/cdn/nzy101. eCollection 2019 Feb.
- Derived from this study: PubMed 29702295Pohl D, Van Oudenhove L, Tornblom H, Le Neve B, Tack J, Simren M. Functional Dyspepsia and Severity of Psychologic Symptoms Associate With Postprandial Symptoms in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1745-1753.e1. doi: 10.1016/j.cgh.2018.04.034. Epub 2018 Apr 24.
- Derived from this study: PubMed 27725146Tap J, Derrien M, Tornblom H, Brazeilles R, Cools-Portier S, Dore J, Storsrud S, Le Neve B, Ohman L, Simren M. Identification of an Intestinal Microbiota Signature Associated With Severity of Irritable Bowel Syndrome. Gastroenterology. 2017 Jan;152(1):111-123.e8. doi: 10.1053/j.gastro.2016.09.049. Epub 2016 Oct 7.
- Derived from this study: PubMed 26492847Le Neve B, Brazeilles R, Derrien M, Tap J, Guyonnet D, Ohman L, Tornblom H, Simren M. Lactulose Challenge Determines Visceral Sensitivity and Severity of Symptoms in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2016 Feb;14(2):226-33.e1-3. doi: 10.1016/j.cgh.2015.09.039. Epub 2015 Oct 20.
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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.
Magnus Simrén, MD, PhD principal investigator
Sahlgrenska University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activia® (125g/pot) and Acidified non-fermented dairy product in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 3 sites in Sweden.
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 12 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
IBS symptoms (time frame: 8 Weeks). 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 NCT01252550, which also lists 6 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 18 Nov 2014.