The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level

NCT02980406 | Completed

• 1 other identifier: FODMAP1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Irritable Bowel Syndrome

Keywords

FODMAP; Irritable bowel syndrome; Gastric accommodation; Gastric motility; brain-gut axis

Outcome Measures

Primary Outcomes (1)

• Change in intragastric pressure measured by high resolution manometry

  Intragastric pressure will be assessed as a measure for gastric accommodation and gastric motility

  up to 3 hours after administration

Secondary Outcomes (5)

• Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm

  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.

  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.

  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).

  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.

  STAI (State Trait Anxiety) before, after, 1h, 2h and 3h after administration.

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: Glucose (control)

Interventions

FODMAP DIETARY_SUPPLEMENT

Fermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients.

FODMAP mix; Fructans; Fructose

Glucose (control) DIETARY_SUPPLEMENT

Glucose is not a FODMAP.

Glucose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 to 65 years old

You may not qualify if:

• 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:
• 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
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (1)

• 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.

  PMID: 28762592 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet; Glucose

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Jan Tack, MD, PhD

  UZ Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: December 2, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share