UZ Brussel
Jette, Brussels Capital, 1090, Belgium
Location status: Recruiting
Location contact
Sébastien Kindt, MD
CONTACT
NCT Number: NCT04974593
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Jette, Brussels Capital, 1090, Belgium
Location status: Recruiting
Sébastien Kindt, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A trained dietitian will provide instruction of the LFD according to standard practice.
Time frame: from baseline till visit 4 (week 4)
To compare the symptomatic improvement by a LFD in Rome IV IBS patients with and without LM according to a H2BT.
Time frame: baseline till visit 4 (week 4)
reduction in IBS-SSS at the end of 4 weeks of a LFD in Rome IV IBS subjects identified as lactose mal-absorbers vs. lactose absorbers by lactose H2BT
Contact information is provided by the study sponsor or research team.
Universitair Ziekenhuis Brussel
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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