IBS - Irritable Bowel SyndromeNCT04543474
Treatment Efficacy of Low FODMAP Versus Low Lactose Diet in IBS Patients
A study testing Low Lactose Diet and Low FODMAP Diet in people with IBS - Irritable Bowel Syndrome, run by Cantonal Hospital of St. Gallen.
Trial summary
A low FODMAP diet (LFD) has become a standard treatment in irritable bowel syndrome (IBS) patients. Compliant adherence to a LFD is challenging. The investigator looked at the effect of a LFD compared to a less restrictive low lactose diet (LLD) in a randomized cross-over trial with IBS patients. 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?
- Low Lactose Diet and Low FODMAP Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2015to 19 Dec 2017
- 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
- functional bowel symptoms as defined by the Rome IV criteria
- subjective lactose intolerance
Who cannot join
- pharmacologic agents to alter symptoms (laxatives, antidiarrheal agents)
- smoking
- antibiotic therapy within the last 4 weeks
- gastrointestinal diseases (Celiac disease was excluded by negative serologic testing while on a gluten containing diet
- any type of food allergy
About this study
Official title: Treatment Efficacy of a Low FODMAP Diet Compared to a Low Lactose Diet in IBS Patients: a Randomized, Cross-over Designed Study
A low FODMAP diet (LFD) has become a standard treatment in irritable bowel syndrome (IBS) patients. Compliant adherence to a LFD is challenging. The investigator looked at the effect of a LFD compared to a less restrictive low lactose diet (LLD) in a randomized cross-over trial with IBS patients.
Read the detailed description
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder. It affects 10 - 20% of the adult population. Pharmaceutical therapy as bulking agents, anticholinergics, antispasmodics, and antidiarrheals are mostly unsatisfactory and many gastroenterologists recommend therefore dietary management. Most patients note that various foods elicit abdominal symptoms and therefore restrict their diet .
The low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet has currently the greatest evidence for efficacy in IBS. The rationale behind the LFD is the exclusion of poorly absorbed short-chain carbohydrates which would create an osmotic load, drag fluid into the small intestine and would be fermented by the colonic microbiome, both leading to abdominal distention and increased luminal influx. FODMAPs do not cause symptoms in healthy adults as they neither show these abnormalities in gut physiology nor suffer from visceral hypersensitivity .
It is not known however whether change in symptoms is induced by a reduction in all FODMAPs or simply a single component as for example lactose. If there is a lactase deficiency, as it is the case in 2-20% of Central- / Northern Europeans, lactose cannot be hydrolysed and causes the above mentioned symptoms. Many IBS patients avoid lactose, even though only few have a lactase deficiency. Lactose intolerance but not lactase deficiency is more frequent in patients with IBS. The investigator wanted to examine if the demanding LFD is more effective than elimination of lactose alone.
Our study, comparing in detail the effects of low FODMAP versus low lactose diet in IBS patients is a novelty, analysing a clinically highly relevant topic.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Low Lactose Diet, Low FODMAP Diet
- 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.
Low Lactose DietOther
First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.
Low FODMAP DietOther
First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Patients starting with a low lactose diet for 3 weeks, followed by a wash out phase of 3 week, before crossing over to the low FODMAP diet for 3 weeks Receives: Other: Low Lactose Diet; Other: Low FODMAP Diet |
| Group 2 | Active comparator | Patients starting with a low FODMAP diet for 3 weeks, followed by a wash out phase of 3 week, before crossing over to the low lactose diet for 3 weeks. Receives: Other: Low Lactose Diet; Other: Low FODMAP Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from gastrointestinal symptoms in Irritable Bowel Syndrome (IBS symptom severity score) from Baseline to "post intervention diet".
The symptom severity score (IBS-SSS) is a validated score to evaluate the severity of an IBS. The five subscores for abdominal pain (severity and frequency), abdominal distension, satisfaction with stool habits and interference of IBS with daily life were each rated on a VAS (visual analogue scale) 0-100 mm scale and added up to a maximal sum of 500. A total score of 75 - 175 was regarded as mild, 175 - 300 as moderate and > 300 as severe IBS.
Measured: The IBS SSS was assessed at the end of the run in period and at the end of the intervention diets (low lactose and low FODMAP diet) at day 14, 35 and 77.
Secondary outcomes (9)
IBS symptom severity subscore "abdominal pain severity"
The subscore (abdominal pain severity was assessed individually, on a VAS (visual analogue scale) 0-100 mm scale (the less, the better)
Measured: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS- symptom severity subscore "abdominal pain frequency"
The subscore abdominal pain frequency was assessed individually on a VAS (visual analogue scale) 0-100 mm scale (the less, the better)
Measured: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS- symptom severity subscore "abdominal distension"
The subscore abdominal distension was assessed individually on a VAS (visual analogue scale) 0-100 mm scale (the less, the better)
Measured: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS symptom severity subscore "satisfaction with stool habits"
The subscore satisfaction with stool habits was assessed individually on a VAS (visual analogue scale) 0-100 mm scale (the less the better).
Measured: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS symptom severity subscore "interference of IBS with daily life"
The subscore satisfaction with stool habits was assessed individually on a VAS (visual analogue scale) 0-100 mm scale (the less, the better)
Measured: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS symptom severity score
The symptom severity score (IBS-SSS) is a validated score to evaluate the severity of an IBS. The five subscores for abdominal pain (severity and frequency), abdominal distension, satisfaction with stool habits and interference of IBS with daily life were each rated on a VAS 0-100 mm scale and added up to a maximal sum of 500. A total score of 75 - 175 was regarded as mild, 175 - 300 as moderate and > 300 as severe IBS.
Measured: IBS SSS (total) was assessed at the end of the run-in (day 14), and wash-out phase (day 56).
Stool frequency
Patients recorded stool frequency
Measured: Stool frequency was assessed daily throughout the study (day 1-77).
Stool consistency
Patients recorded stool consistency according to the Bristol Stool Chart (BSC) Type 1 hard lumps, Type 2 sausage shaped but lumpy, Type 3 sausage with cracks, Type 4 smooth sausage, Type 5 soft blobs, Type 6 fluffy pieces, Type 7 entirely liquid.
Measured: Stool consistency was assessed daily throughout the study (day 1-77).
Body weight
Body weight in kg.
Measured: Body weight was assesses at the beginning of the study (day 1) and at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start11 Mar 2015
- Primary completion19 Sep 2017
- Study completion19 Dec 2017
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Krieger-Grübel, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543474
- Sponsor's protocol ID
- 130225
- Status last verified
- Sep 2020
- First submitted
- 15 Aug 2020
- Last updated
- 10 Sep 2020
- 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 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy of a Low FODMAP Diet Compared to a Low Lactose Diet in IBS Patients: a Randomized, Cross-over Designed Study
- ClinicalTrials.gov ID
- NCT04543474
- Acronym / sponsor ID
- 130225
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 11 Mar 2015 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 10 Sep 2020 (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.
A low FODMAP diet (LFD) has become a standard treatment in irritable bowel syndrome (IBS) patients. Compliant adherence to a LFD is challenging. The investigator looked at the effect of a LFD compared to a less restrictive low lactose diet (LLD) in a randomized cross-over trial with IBS patients.
Detailed description
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder. It affects 10 - 20% of the adult population. Pharmaceutical therapy as bulking agents, anticholinergics, antispasmodics, and antidiarrheals are mostly unsatisfactory and many gastroenterologists recommend therefore dietary management. Most patients note that various foods elicit abdominal symptoms and therefore restrict their diet .
The low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet has currently the greatest evidence for efficacy in IBS. The rationale behind the LFD is the exclusion of poorly absorbed short-chain carbohydrates which would create an osmotic load, drag fluid into the small intestine and would be fermented by the colonic microbiome, both leading to abdominal distention and increased luminal influx. FODMAPs do not cause symptoms in healthy adults as they neither show these abnormalities in gut physiology nor suffer from visceral hypersensitivity .
It is not known however whether change in symptoms is induced by a reduction in all FODMAPs or simply a single component as for example lactose. If there is a lactase deficiency, as it is the case in 2-20% of Central- / Northern Europeans, lactose cannot be hydrolysed and causes the above mentioned symptoms. Many IBS patients avoid lactose, even though only few have a lactase deficiency. Lactose intolerance but not lactase deficiency is more frequent in patients with IBS. The investigator wanted to examine if the demanding LFD is more effective than elimination of lactose alone.
Our study, comparing in detail the effects of low FODMAP versus low lactose diet in IBS patients is a novelty, analysing a clinically highly relevant topic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Low Lactose Diet, Other: Low FODMAP DietPatients starting with a low lactose diet for 3 weeks, followed by a wash out phase of 3 week, before crossing over to the low FODMAP diet for 3 weeks |
| Group 2 | Active comparator | Other: Low Lactose Diet, Other: Low FODMAP DietPatients starting with a low FODMAP diet for 3 weeks, followed by a wash out phase of 3 week, before crossing over to the low lactose diet for 3 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- functional bowel symptoms as defined by the Rome IV criteria
- subjective lactose intolerance
Key exclusion criteria (5 listed)
- pharmacologic agents to alter symptoms (laxatives, antidiarrheal agents)
- smoking
- antibiotic therapy within the last 4 weeks
- gastrointestinal diseases (Celiac disease was excluded by negative serologic testing while on a gluten containing diet
- any type of food allergy
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 |
|---|---|---|
| Low Lactose DietFirst, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study. | Other | Group 1, Group 2 |
| Low FODMAP DietFirst, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study. | Other | Group 1, Group 2 |
Primary outcome
Change from gastrointestinal symptoms in Irritable Bowel Syndrome (IBS symptom severity score) from Baseline to "post intervention diet".
Time frame: The IBS SSS was assessed at the end of the run in period and at the end of the intervention diets (low lactose and low FODMAP diet) at day 14, 35 and 77.
The symptom severity score (IBS-SSS) is a validated score to evaluate the severity of an IBS. The five subscores for abdominal pain (severity and frequency), abdominal distension, satisfaction with stool habits and interference of IBS with daily life were each rated on a VAS (visual analogue scale) 0-100 mm scale and added up to a maximal sum of 500. A total score of 75 - 175 was regarded as mild, 175 - 300 as moderate and > 300 as severe IBS.
9 secondary outcomes
IBS symptom severity subscore "abdominal pain severity"
Time frame: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS- symptom severity subscore "abdominal pain frequency"
Time frame: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS- symptom severity subscore "abdominal distension"
Time frame: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS symptom severity subscore "satisfaction with stool habits"
Time frame: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS symptom severity subscore "interference of IBS with daily life"
Time frame: IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.
IBS symptom severity score
Time frame: IBS SSS (total) was assessed at the end of the run-in (day 14), and wash-out phase (day 56).
Stool frequency
Time frame: Stool frequency was assessed daily throughout the study (day 1-77).
Stool consistency
Time frame: Stool consistency was assessed daily throughout the study (day 1-77).
Body weight
Time frame: Body weight was assesses at the beginning of the study (day 1) and at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77).
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 10 Sep 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Low Lactose Diet and Low FODMAP Diet in people with IBS - Irritable Bowel Syndrome, run by Cantonal Hospital of St. Gallen.
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 2 inclusion and 5 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 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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 gastrointestinal symptoms in Irritable Bowel Syndrome (IBS symptom severity score) from Baseline to "post intervention diet". (time frame: The IBS SSS was assessed at the end of the run in period and at the end of the intervention diets (low lactose and low FODMAP diet) at day 14, 35 and 77.). 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 10 Sep 2020.