Reassessment of the biological variation of the lactulose mannitol test in healthy volunteers,in patients one year after bariatric surgery, and in patients with inflammatory bowel disease

Reassessment of the biological variation of the lactulose mannitol test in healthy volunteers,in patients one year after bariatric surgery, and in patients with inflammatory bowel disease - LacMan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53298

Enrollment

Registered

2023-02-15

Start date

2025-12-01

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal permeability intestinal wall permeability

Interventions

This is a non-therapeutic, observational study. No medicinal product or experimental treatment will be administered. The interventions consist solely of a blood sample and the performance of the lactu

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers:- Provide written informed consent - Age >= 18 years old - BMI < 30 kg/m2 Patients after bariatric surgery:-Provide written informed consent - Age >= 18 years old - One year after OAGB or RYGB Patients with Inflammatory bowel diseases (IBD):-Provide written informed consent - Age >= 18 years old - At least one year after diagnosis of IBD 

Exclusion criteria

Exclusion criteria: The usage of NSAIDs (e.g. ibuprofen, naproxen, diclofenac, acetylsalicylic  acid) within the prior week or during the study. Chronic use of diuretics Chronic use of antibiotics Pregnancy Alcohol consumption of >8 units/week The use of tobacco products within the prior week Exclusive for healthy volunteers and Patients after bariatric surgery:The presence of gastrointestinal diseases (e.g., Crohn*s disease, ulcerative  colitis, irritable bowel disease, gastric cancer) including stomach and  intestinal complaints

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is the lactulose/mannitol ratio of 0-2, 2-5 and 0-5 hours-urine and the coefficient of variation of the lactulose mannitol ratios. The results of different healthy volunteers will be compared to each other (inter-individual variation) as well as the results of one healthy volunteer on a different day (intra-individual variation)For the IBD patients, several blood biomarkers will also be collected as the primary outcome measure.	—

Measure

Time frame

The primary outcome of the study is the lactulose/mannitol ratio of 0-2, 2-5 and 0-5 hours-urine and the coefficient of variation of the lactulose mannitol ratios. The results of different healthy volunteers will be compared to each other (inter-individual variation) as well as the results of one healthy volunteer on a different day (intra-individual variation)For the IBD patients, several blood biomarkers will also be collected as the primary outcome measure.

—

Secondary

Measure	Time frame
A possible outcome is the implementation of the lactulose mannitol test as a standard test in the UMCG. Therefore, participants are asked to fill in a questionnaire about how they experienced the collection of urine and fasting. The questionnaire only has to be filled in after the first measurement.	—

Countries

Netherlands

Contacts

Public ContactS Geertsema

Universitair Medisch Centrum Groningen

s.geertsema@umcg.nl+31 (06) 552 56 696

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)