Cancer patients after ICI treatment or after autologous stem cell transplantation
Conditions
Interventions
Group 1: First visit to the clinic (day 0):
- Blood sample (approx. 22 ml)
- Stool sample
- 4 short questionnaires on quality of life and gastrointestinal complaints
Introduction to the planned chang
Sponsors
Universitätsmedizin Frankfurt
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: o Body Mass Index 18.5–40 kg/m2 o ECOG performance status of 0-1 o German or English-speaking o Ability to give inform consent o Self-reported willingness to comply with dietary modification o Self-reported willingness to comply with scheduled visits, provide blood and stool samples o Self-reported willingness to fill out study required questionnaires o Currently under treatment with ICI
Exclusion criteria
Exclusion criteria: o Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment o History of total colectomy or bariatric surgery o Medical contraindications to intervention as determined by the treating physician o Heavy drinker (defined as > 14 drinks per week) or current self-reported illicit drug use o Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements. o Plan for travel or any other activity during the study that would preclude adherence to prescribed diets o Current consumption of fiber =20g or fermented food =3 portions a day. o History of active uncontrolled gastrointestinal disorders or diseases, including: - Inflammatory bowel disease (IBD), including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis. - Irritable bowel syndrome (IBS) (moderate-severe). - Malabsorption (e.g active celiac disease) - Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent), or Helicobacter pylori infection (untreated) o Regularly taking probiotics, fiber supplements, or any other medication or pre-biotic dietary supplement that could affect the study outcome as determined by the principal investigator and unable/unwilling to discontinue for the study. These agents must be discontinued at least 14 days prior to the start of the diet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the feasibility and safety of a combined high-fermented food and high- fiber diet This will be checked at different timepoints via stool sample analysis and questionnaire feedback | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the effect of a high-fermented food and high- fiber diet on the composition and diversity of the gut microbiome - To assess the effect of a high-fermented food and high- fiber diet on the metabolic output of the gut microbiome - To assess the effect of a high-fermented and high- fiber diet on the quality of life and psychological symptoms This will be checked at different timepoints via stool sample analysis and questionnaire feedback | — |
Countries
Germany
Contacts
Public ContactTheresa Alisch
Universitätsmedizin Frankfurt
Outcome results
None listed