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Study identifier: NCT04974593 Synced from ClinicalTrials.gov · July 28, 2026
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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.

Condition: Irritable Bowel Syndrome · Lactose Intolerant  ·  Sponsor: Universitair Ziekenhuis Brussel

PhasePhase 3
Planned participants90
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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. Moreov…

This description comes directly from the study's public registry record.

Talk to the study team

Sébastien Kindt, MD  ·  +32 2 476  ·  Sebastien.kindt@uzbrussel.be

Always discuss trial participation with your own doctor first.

Locations (1)

UZ BrusselJette, Brussels Capital, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT04974593