Does Cholestyramine/Colesevelam and Probenecid increase the excretion of Perfluoroalkyl substances? An study of individuals with high levels of Perfluoroalkyl substances in Ronneby, Sweden.

Does Cholestyramine/Colesevelam and Probenecid increase the elimination of Perfluoroalkyl substances? An experimental study of highly exposed individuals in Ronneby, Sweden.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005865-42-SE

Enrollment

Registered

2022-03-24

Start date

2022-05-11

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

An intervention trial on healthy subjects to study the importance of enterohepatic recirculation and renal organic anion transporters on elimination of Perfluoroalkyl substances (PFAS). The intervention will consist of two different medications - Cholestyramine/colesevelam and Probenecid. The effects will be evaluated in healthy subjects with high PFAS-levels. MedDRA version: 20.1 Level: LLT Classification code 10050654 Term: Toxicology NOS System Organ Class: 10022891 - Investigations MedDRA

Interventions

Product Name: Kolestyramin Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: COLESTYRAMINE ANHYDROUS Current Sponsor code: Cholestyramine Concentration unit: g gram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Men and women aged 20-45 • Previous participation in Ronneby Biomarker cohort, established 2014-15. • Given informed, written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: • Contraindications towards the study medications • Medication that interacts with the study medications • Previous or current kidney, liver or inflammatory bowel disease • Chronic, systemic disease • Known or suspected allergy against any of the medications • Pregnant or lactating women, or women who plan to be pregnant during the trial • Treatment or disease that according to the investigator might affect the treatment or the study results • Intellectual disability, reluctance or language barriers that entail difficulties in understanding participation in the study. • Participation in another clinical, intervention study (except for our vaccine study)

Design outcomes

Primary

Measure	Time frame
Main Objective: The general aim is to study the importance of enterohepatic recirculation and renal organic anion transporters on elimination of Perfluoroalkyl substances (PFAS). In order to study this aim, this study is divided into two parts – a proof-of-concept, shorter trial; and a longer follow-up trial. Specific research questions for part 1 (proof-of-concept): •Does a one-week Cholestyramine treatment lead to an increased elimination of PFAS in faeces? •Does a one-week Probenecid treatment lead to an increased elimination of PFAS in urine? Depending on the results in part 1, the following specific research questions can be applicable for part 2: •Does a twelve weeks Colesevelam treatment lead to an increased elimination rate of PFAS? •Is there an additive or synergistic effect of combined twelve-week Colesevelam and Probenecid treatment? What is the maximum effect? ;Secondary Objective: Not applicable;Primary end point(s): Part 1: Change of PFAS in faeces and in urine during the treatment period. Part 2: Change of PFAS in serum during the treatment period.;Timepoint(s) of evaluation of this end point: Before, during and after each treatment period. Part 1: 1 week with each treatment, with cross-over design so that every participant gets each treatment and being control. Part 2: 12 week with each treatment, with cross-over design so that every participant gets each treatment and being control.	—

Measure

Time frame

Main Objective: The general aim is to study the importance of enterohepatic recirculation and renal organic anion transporters on elimination of Perfluoroalkyl substances (PFAS). In order to study this aim, this study is divided into two parts – a proof-of-concept, shorter trial; and a longer follow-up trial. Specific research questions for part 1 (proof-of-concept): •Does a one-week Cholestyramine treatment lead to an increased elimination of PFAS in faeces? •Does a one-week Probenecid treatment lead to an increased elimination of PFAS in urine? Depending on the results in part 1, the following specific research questions can be applicable for part 2: •Does a twelve weeks Colesevelam treatment lead to an increased elimination rate of PFAS? •Is there an additive or synergistic effect of combined twelve-week Colesevelam and Probenecid treatment? What is the maximum effect? ;Secondary Objective: Not applicable;Primary end point(s): Part 1: Change of PFAS in faeces and in urine during the treatment period. Part 2: Change of PFAS in serum during the treatment period.;Timepoint(s) of evaluation of this end point: Before, during and after each treatment period. Part 1: 1 week with each treatment, with cross-over design so that every participant gets each treatment and being control. Part 2: 12 week with each treatment, with cross-over design so that every participant gets each treatment and being control.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Sweden

Contacts

Public ContactAxel Andersson

University Of Gothenburg

axel.andersson.2@gu.se+4631786 68 40

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026