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CompletedNCT02212821Updated Nov 30, 2016

Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects

A Phase 4 interventional study of Erythromycin and Placebo in Healthy Volunteers, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-30.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female only.
  • Age > 18 and \< 60.
  • Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5 kg in the past three months).
  • Not known to have any chronic medical illness or illnesses affecting the gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric disorder.
  • If female not known to be pregnant.
  • Not known to have any past upper gastrointestinal surgery.

Exclusion criteria

Exclusion Criteria:

  • Alcohol consumption > 7 drinks / week
  • Major depression and chronic health conditions except controlled hypertension
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
14 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    intravenous infusion

    Drug: Placebo

  • Experimental
    Erythromycin

    intravenous infusion

    Drug: Erythromycin

Interventions

  • DrugErythromycin
  • DrugPlacebo

    physiological saline

06

What researchers measure

Primary outcomes

  1. Functional brain images

    The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM.

    Time frame: 40 min after intervention

Secondary outcomes

  1. hunger scores

    The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale.

    Time frame: every 10 minutes since the scan starts

  2. gut hormones

    Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure gut hormones (motilin, ghrelin, CCK, PYY, GLP-1) by radioimmuno-assay.

    Time frame: every 10 min since the scan starts

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02212821
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
Responsible party
Sponsor
First posted
Aug 8, 2014
Start date
Sep 2014
Primary completion
Sep 2016
Last update
Nov 30, 2016

Study contacts

Jan Tack
principal investigator · University of Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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