Irritable Bowel SyndromeNCT02980406
The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
A study testing FODMAP in people with Irritable Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers and 20 patients with irritable bowel syndrome (IBS) will undergo respectively four and two/three pressure measurements of the stomach after an… 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?
- FODMAP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jun 2016
- 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
- Aged between 18 to 65 years old
- Meet Rome III criteria for IBS. This is defined as recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following: improvement with defecation; onset associated with a change in frequency of stool; or onset associated with a change in form (appearance) of stool
- Aged between 18 to 65 years old
Who cannot join
- Current symptoms or history of gastrointestinal disease, other significant diseases, psychological disorders, drug allergies or pregnancy
- Taking any medication or have any drug history
- IBS patients:
- Other significant diseases, psychological disorder, drug allergies or pregnancy
- Taking any non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids or other immunosuppressive drugs in the preceding 6 months. All drugs potentially affecting gastrointestinal motility or sensitivity will be discontinued at least 1 week before the gastric emptying study.
About this study
In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers and 20 patients with irritable bowel syndrome (IBS) will undergo respectively four and two/three pressure measurements of the stomach after an overnight fast as a measure for gastric motility. During this pressure measurement, which takes approximately 4 hours, one of four FODMAP or control solutions will be administered directly into the stomach through a nasogastric tube. Administration will be stopped when the participant is fully satiated. The four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients, only the fructan and glucose solution will be tested, where after they can choose to come for a third visit to test the fructose solution. The solutions will be tested on separate occasions in a randomized order.
During the pressure measurement, participants will be asked to complete several questionnaires: (1) a gastrointestinal symptom questionnaire to assess their gastrointestinal symptoms, (2) a satiation questionnaire during infusion of one of the solutions, (3) psychological questionnaires (POMS, SAM, PANAS and STAI) to evaluate possible psychological effects of FODMAP infusion.
The investigators hypothesize that there will be differences in gastric motility between healthy volunteers and IBS patients. Furthermore, it is hypothesized that gastrointestinal symptoms will be increased in IBS patients, and that FODMAP infusion will have more psychological effects in patients than in healthy volunteers.
Read the detailed description
In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric motility and on gastrointestinal and psychological symptoms. This is a randomised, single-blinded, crossover study of different solutions, differing in FODMAP content. The four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients, only the fructan and glucose solution will be tested, where after they can choose to come for a third visit to test the fructose solution. The different solutions will be tested on separate occasions, three days to one week apart, in a randomised order.
The preparation of each study visit will be identical. After an overnight fast, participants will be asked to come to the clinic. To ensure a low baseline symptom level and low microbial gut activity, a diet low in fibre and fermentable carbohydrates will be followed the day prior to each test (information will be provided to assist this). Participants will be asked to refrain from alcohol, tea and coffee, and intense physical activity for at least 12 hours before participation. They will also be asked to refrain from smoking cigarettes at least one hour before the start of the experiment.
A high resolution manometry probe will be inserted through the nose into the stomach of the participant to assess intragastric pressure as a measure of gastric motility and gastric accommodation. In addition, an infusion tube will be positioned in the proximal stomach to administer the solution. The position of the probes will be checked fluoroscopically (maximum 15 seconds). In this case, relevant guidelines of radioprotection will be adhered to. Patients will be protected by a lead shield that covers the lower abdomen and all personnel will wear a lead jacket. After the catheters are fixed to the subjects' chin, the patients will be asked to sit at a table and remain in this position for the remainder of the experiment.
After a stabilization period of at least 15 minutes, and when the subject is in phase II of the hunger cycle, one of four solutions will be intragastrically administered at a constant speed of 60 mL per minute (determined by an automated system using a peristaltic pump). IGP will be recorded for the duration of the drink infusion and for the following 3 hours. During infusion, the subjects will be asked to score their satiation at 1-minute intervals using a graphic rating scale that combines verbal descriptors on a scale graded of 0-5 (1, threshold; 5, maximum satiety). The intragastric infusion will be stopped as soon as a score of 5 is reached on their satiation scores. In addition, participants will be asked to complete a gastrointestinal symptom questionnaire every 15 minutes. The participant's emotions and mood will be assessed before, immediately after and 1, 2 and 3 hours after infusion, using the State-Trait Anxiety Inventory (STAI) and the validated Dutch version of the Positive and Negative Affect Scale (PANAS). Emotional state will be repeatedly measured every 15 minutes using the Self-Assessment Manikin (SAM) and Profile of Mood States (POMS)-Fatigue subscale.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- FODMAP, Glucose (control)
- Keywords
- FODMAP, Irritable bowel syndrome, Gastric accommodation, Gastric motility, brain-gut axis
- 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.
FODMAPDietary supplement
Fermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients.
Glucose (control)Dietary supplement
Glucose is not a FODMAP.
| Study group | Role | What they receive |
|---|---|---|
| Fructans | Active comparator | Fructans (FODMAP) are oligosaccharides containing fructose chains. Since the human body lacks hydrolases to break down these saccharides, fructans are poorly absorbed molecules in everybody. The fructan solution used in this study has a concentration of 38g/L. Receives: Dietary Supplement: FODMAP |
| Fructose | Active comparator | Fructose can be found in the diet as free fructose, in sucrose or as polymer structure in fructans. Absorption varies and occurs more rapidly in the presence of glucose than for free fructose because glucose cotransport is involved in the uptake of fructose. Therefore, when fructose is in excess of glucose, it is regarded as a FODMAP. The fructose concentration used in this study is 100g/L. Receives: Dietary Supplement: FODMAP |
| FODMAP mix | Active comparator | The FODMAP mix consists of 20g fructans, 10g galacto-oligosaccharides (GOS), 30g fructose, 10g sorbitol and 10g mannitol in one liter of tap water. Receives: Dietary Supplement: FODMAP |
| Glucose | Placebo comparator | Glucose is a carbohydrate that is not classified as FODMAP, and is therefore used as a control in this study. The concentration of the glucose solution in this study is 100g/L. Receives: Dietary Supplement: Glucose (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intragastric pressure measured by high resolution manometry
Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility
Measured: up to 3 hours after administration
Secondary outcomes (5)
Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
Measured: assessment by questionnaire (100 mm Visual Analogue Scale) every 15 minutes, up to 3 hours after administration
Change in mood/emotion measured by Profile Of Mood States (POMS) questionnaire.
Measured: POMS (Profile Of Mood States) every 15 minutes up to 3 hours after administration.
Change in mood/emotion measured by Self Assessment Manikin (SAM) questionnaire.
Measured: SAM (Self Assessment Manikin) every 15 minutes up to 3 hours after administration.
Change in mood/emotion measured by Positive and Negative Affect Scale (PANAS).
Measured: PANAS (Positive And Negative Affect Scale) before, after, 1h, 2h and 3h after administration.
Change in mood/emotion measured by State Trait Anxiety Index questionnaire.
Measured: STAI (State Trait Anxiety) before, after, 1h, 2h and 3h after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, PhD, Principal investigator, UZ Leuven / KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980406
- Sponsor's protocol ID
- FODMAP1
- Status last verified
- May 2016
- First submitted
- 2 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Masuy I, Van Oudenhove L, Tack J, Biesiekierski JR. Effect of intragastric FODMAP infusion on upper gastrointestinal motility, gastrointestinal, and psychological symptoms in irritable bowel syndrome vs healthy controls. Neurogastroenterol Motil. 2018 Jan;30(1). doi: 10.1111/nmo.13167. Epub 2017 Aug 1.
PubMed 28762592
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level
- ClinicalTrials.gov ID
- NCT02980406
- Acronym / sponsor ID
- FODMAP1
- Conditions
- Irritable Bowel Syndrome
- Keywords
- FODMAP, Irritable bowel syndrome, Gastric accommodation, Gastric motility, brain-gut axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Dec 2016 (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.
In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric motility and on gastrointestinal and psychological symptoms. 20 healthy volunteers and 20 patients with irritable bowel syndrome (IBS) will undergo respectively four and two/three pressure measurements of the stomach after an overnight fast as a measure for gastric motility. During this pressure measurement, which takes approximately 4 hours, one of four FODMAP or control solutions will be administered directly into the stomach through a nasogastric tube. Administration will be stopped when the participant is fully satiated. The four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients, only the fructan and glucose solution will be tested, where after they can choose to come for a third visit to test the fructose solution. The solutions will be tested on separate occasions in a randomized order.
During the pressure measurement, participants will be asked to complete several questionnaires: (1) a gastrointestinal symptom questionnaire to assess their gastrointestinal symptoms, (2) a satiation questionnaire during infusion of one of the solutions, (3) psychological questionnaires (POMS, SAM, PANAS and STAI) to evaluate possible psychological effects of FODMAP infusion.
The investigators hypothesize that there will be differences in gastric motility between healthy volunteers and IBS patients. Furthermore, it is hypothesized that gastrointestinal symptoms will be increased in IBS patients, and that FODMAP infusion will have more psychological effects in patients than in healthy volunteers.
Detailed description
In this study, the investigators aim to assess the effect of acute FODMAP infusion on gastric motility and on gastrointestinal and psychological symptoms. This is a randomised, single-blinded, crossover study of different solutions, differing in FODMAP content. The four solutions that will be tested in healthy volunteers are (1) a fructan solution, (2) a fructose solution, (3) a FODMAP mix and (4) a glucose solution as a control. In IBS patients, only the fructan and glucose solution will be tested, where after they can choose to come for a third visit to test the fructose solution. The different solutions will be tested on separate occasions, three days to one week apart, in a randomised order.
The preparation of each study visit will be identical. After an overnight fast, participants will be asked to come to the clinic. To ensure a low baseline symptom level and low microbial gut activity, a diet low in fibre and fermentable carbohydrates will be followed the day prior to each test (information will be provided to assist this). Participants will be asked to refrain from alcohol, tea and coffee, and intense physical activity for at least 12 hours before participation. They will also be asked to refrain from smoking cigarettes at least one hour before the start of the experiment.
A high resolution manometry probe will be inserted through the nose into the stomach of the participant to assess intragastric pressure as a measure of gastric motility and gastric accommodation. In addition, an infusion tube will be positioned in the proximal stomach to administer the solution. The position of the probes will be checked fluoroscopically (maximum 15 seconds). In this case, relevant guidelines of radioprotection will be adhered to. Patients will be protected by a lead shield that covers the lower abdomen and all personnel will wear a lead jacket. After the catheters are fixed to the subjects' chin, the patients will be asked to sit at a table and remain in this position for the remainder of the experiment.
After a stabilization period of at least 15 minutes, and when the subject is in phase II of the hunger cycle, one of four solutions will be intragastrically administered at a constant speed of 60 mL per minute (determined by an automated system using a peristaltic pump). IGP will be recorded for the duration of the drink infusion and for the following 3 hours. During infusion, the subjects will be asked to score their satiation at 1-minute intervals using a graphic rating scale that combines verbal descriptors on a scale graded of 0-5 (1, threshold; 5, maximum satiety). The intragastric infusion will be stopped as soon as a score of 5 is reached on their satiation scores. In addition, participants will be asked to complete a gastrointestinal symptom questionnaire every 15 minutes. The participant's emotions and mood will be assessed before, immediately after and 1, 2 and 3 hours after infusion, using the State-Trait Anxiety Inventory (STAI) and the validated Dutch version of the Positive and Negative Affect Scale (PANAS). Emotional state will be repeatedly measured every 15 minutes using the Self-Assessment Manikin (SAM) and Profile of Mood States (POMS)-Fatigue subscale.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fructans | Active comparator | Dietary Supplement: FODMAPFructans (FODMAP) are oligosaccharides containing fructose chains. Since the human body lacks hydrolases to break down these saccharides, fructans are poorly absorbed molecules in everybody. The fructan solution used in this study has a concentration of 38g/L. |
| Fructose | Active comparator | Dietary Supplement: FODMAPFructose can be found in the diet as free fructose, in sucrose or as polymer structure in fructans. Absorption varies and occurs more rapidly in the presence of glucose than for free fructose because glucose cotransport is involved in the uptake of fructose. Therefore, when fructose is in excess of glucose, it is regarded as a FODMAP. The fructose concentration used in this study is 100g/L. |
| FODMAP mix | Active comparator | Dietary Supplement: FODMAPThe FODMAP mix consists of 20g fructans, 10g galacto-oligosaccharides (GOS), 30g fructose, 10g sorbitol and 10g mannitol in one liter of tap water. |
| Glucose | Placebo comparator | Dietary Supplement: Glucose (control)Glucose is a carbohydrate that is not classified as FODMAP, and is therefore used as a control in this study. The concentration of the glucose solution in this study is 100g/L. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 to 65 years old
- Meet Rome III criteria for IBS. This is defined as recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following: improvement with defecation; onset associated with a change in frequency of stool; or onset associated with a change in form (appearance) of stool
- Aged between 18 to 65 years old
Key exclusion criteria (5 listed)
- Current symptoms or history of gastrointestinal disease, other significant diseases, psychological disorders, drug allergies or pregnancy
- Taking any medication or have any drug history
- Other significant diseases, psychological disorder, drug allergies or pregnancy
- Taking any non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids or other immunosuppressive drugs in the preceding 6 months. All drugs potentially affecting gastrointestinal motility or sensitivity will be discontinued at least 1 week before the gastric emptying 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 |
|---|---|---|
| FODMAPFermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients. | Dietary supplement | FODMAP mix, Fructans, Fructose |
| Glucose (control)Glucose is not a FODMAP. | Dietary supplement | Glucose |
Primary outcome
Change in intragastric pressure measured by high resolution manometry
Time frame: up to 3 hours after administration
Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility
5 secondary outcomes
Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
Time frame: assessment by questionnaire (100 mm Visual Analogue Scale) every 15 minutes, up to 3 hours after administration
Change in mood/emotion measured by Profile Of Mood States (POMS) questionnaire.
Time frame: POMS (Profile Of Mood States) every 15 minutes up to 3 hours after administration.
Change in mood/emotion measured by Self Assessment Manikin (SAM) questionnaire.
Time frame: SAM (Self Assessment Manikin) every 15 minutes up to 3 hours after administration.
Change in mood/emotion measured by Positive and Negative Affect Scale (PANAS).
Time frame: PANAS (Positive And Negative Affect Scale) before, after, 1h, 2h and 3h after administration.
Change in mood/emotion measured by State Trait Anxiety Index questionnaire.
Time frame: STAI (State Trait Anxiety) before, after, 1h, 2h and 3h after administration.
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 2 Dec 2016.
- Derived from this study: PubMed 28762592Masuy I, Van Oudenhove L, Tack J, Biesiekierski JR. Effect of intragastric FODMAP infusion on upper gastrointestinal motility, gastrointestinal, and psychological symptoms in irritable bowel syndrome vs healthy controls. Neurogastroenterol Motil. 2018 Jan;30(1). doi: 10.1111/nmo.13167. Epub 2017 Aug 1.
- 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.
Jan Tack, MD, PhD principal investigator
UZ Leuven / KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing FODMAP in people with Irritable Bowel Syndrome, run by Universitaire Ziekenhuizen KU Leuven.
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 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 2 Dec 2016. 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. 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 in intragastric pressure measured by high resolution manometry (time frame: up to 3 hours after administration). 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 NCT02980406, which also lists 1 linked publication.
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 Dec 2016.