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Predictive Value of Hydrogen/Methane Lactose Breath Testing on the Therapeutic Effect of Lactose-free Diet in Moderate to Severe ROME IV IBS.

NCT04974593 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-18

No results posted yet for this study

Summary

Lactose intolerance (LI) results from lactose malabsorption (LM) secondary to insufficient hydrolysis of the disaccharide lactose into galactose and glucose (Misselwitz 2019). The undigested lactose will eventually reach the colon, resulting in fermentation from colonic bacteria with production of different compounds such as short chain fatty acids, carbon dioxide, H2 and methane (Catanzaro 2021). These compounds have an osmotic effect and can stimulate colonic contractions. These pathophysiological mechanisms encountered in patients suffering from LI generate symptoms, such as abdominal pain and cramps, flatulence, diarrhea, borborygmi among others. As dairy products are highly present in our Western diet, LI will often be considered in patients presenting with these symptoms and they will be referred for further testing. When LM is diagnosed, a lactose-free diet (LFD) will be advocated to alleviate symptoms. However, studies indicate that individuals with LM should tolerate up to 12 g of lactose when administered in a single dose (Suchy 2010).

Irritable bowel syndrome (IBS) is another frequently encountered disorder. According to the Rome IV criteria, it is characterized by abdominal pain associated with a change in stool frequency or consistency, or with symptomatic improvement by defecation (Mearin 2016). Associated symptoms, such as bloating and flatulence, are frequently reported. As such, discerning between IBS and LI based on symptoms alone can be challenging. Moreover lactose is considered part of the so-called fermentable oligo-, di-, monosaccharides and polyols (FODMAPs). A low FODMAP diet has been advocated for IBS with beneficial response in at least part of the patients (Halmos 2014).

Many studies investigated the role of lactose in IBS. These studies were performed in the pre-Rome IV era and before standardized interpretation rules for Hydrogen breath testing (H2BT) were published (meta-analysis by Varju 2019). This meta-analysis indicated that subjective LI was more frequently reported by IBS patients, but also objectively more prevalent in IBS patients, when assessed by any test modality. However, the role of a LFD in IBS remains uncertain.

This study aims to:

* Determine if the diagnosis of LM by H2BT predicts the short-term and long-term response to a LFD in moderate to severe IBS as defined by Rome IV criteria;
* Determine the changes in quality of life in response to a LFD in ROME IV IBS patients.

Conditions

  • Irritable Bowel Syndrome
  • Lactose Intolerant

Interventions

OTHER

low fat diet

A trained dietitian will provide instruction of the LFD according to standard practice.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04974593 on ClinicalTrials.gov