UMCG
Groningen, Provincie Groningen, 9713 GZ, Netherlands
Location status: Recruiting
Location contact
Emily Oosterhout, MSc
CONTACT
G. A.P. Hospers, MD, PhD
CONTACT
G. A.P. Hospers, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07206017
Exploring the effect of supplementation with daily addition of prebiotic dried chicory root (WholeFiberTM) for 6 weeks on fecal SCFA levels, gut microbial composition and immune cell composition in minimal stage II A melanoma patients following surgical treatment.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Groningen, Provincie Groningen, 9713 GZ, Netherlands
Location status: Recruiting
Emily Oosterhout, MSc
CONTACT
G. A.P. Hospers, MD, PhD
CONTACT
G. A.P. Hospers, MD, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion).
Time frame: 6 weeks
Effect of a high fiber prebiotic vegetable (WholeFiber) for 6 weeks on fecal SCFA levels in intermediate to high-risk cutaneous melanoma patients, with no concurrent adjuvant treatment. HPLC ion chromatography system (Metrohm AG, Herisau, Switzerland) will be used to determine the levels of SCFA. The concentrations of SCFA; butyrate, propionate, and acetate will be measured with a conductivity detector. SCFA will be measured at baseline, halfway intervention and after 6 weeks.
Time frame: 6 weeks
Discovering the gut microbial composition changes measured in intermediate to high-risk cutaneous melanoma patients with no concurrent adjuvant treatment, after using WholeFiber for 6 weeks. This analysis will be based on whole genome sequencing of fecal samples performed at the UMCG according to standardized protocol.
Time frame: 6 weeks
Exploring the effect of WholeFiber use for 6 weeks on immune functioning, stool patterns, fecal calprotectin levels and side effects in this patient group. Peripheral blood mononuclear cells (PBMCs) and bloodplasma will be isolated to determine immune cell composition before and after the intervention period. Fecal calprotectin will be determined using the respective ELISA kit (Thermo Fisher Scientific). Calprotectin is released when neutrophils enter the gut wall and are activated during the inflammatory process. Lastly, eating patterns, fiber intake before the interventional period, stool patterns and side effects will be identified using the Food Frequency Questionnaire, Bristol Stool Scale, Gastrointestinal Symptoms Rating Scale and Health Related Quality of Life questionnaires.
Contact information is provided by the study sponsor or research team.
Emily Oosterhout, MSc
CONTACT
G. A.P. Hospers, MD, PhD
CONTACT
University Medical Center Groningen
Other
Measuring Effects of High-fiber Dried Chicory Root on the Gut Microbiota of Patients With an Intermediate to High-risk Cutaneous Melanoma: an Explorative Study
Acronym: MELFIB
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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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