Gastromotal 13C-octanoic acid breath test in the diagnosis and evaluation of therapeutic outcome in patients with dyspeptic symptoms and delayed gastric emptying

Gastromotal 13C-octanoic acid breath test in the diagnosis and evaluation of therapeutic outcome in patients with dyspeptic symptoms and delayed gastric emptying - 13COBT

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002782-38-DE

Enrollment

Registered

2012-04-10

Start date

2012-07-06

Completion date

Unknown

Last updated

2014-01-27

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

Conditions

Patients with dyspeptic symptoms and delayed gastric emptying.

Interventions

Product Name: Gastromotal Product Code: Gastro052011 Pharmaceutical Form: Oral liquid INN or Proposed INN: 1-13C-caprylic acid Current Sponsor code: Gastromotal Other descriptive name: C13-octanoic ac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Male or female patients of at least 18 years of age * Patients suffering from dyspeptic symptoms (GSRS summary score =6, at least 3 symptoms including the symptom fullness or epigastric pain with a score GSRS =2 each) * Exclusion of organic causes for functional dyspepsia by breath test for the presence of H. pylori and gastroscopy within 12 weeks prior to enrolment. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: * Patients with contraindications for the treatment with domperidon (Motilium®): hypersensitivity to domperidon, prolactinome, liver insufficiency, therapy with Ketoconazol-derivates * Patients with medication known to influence gastric emptying * Patient with concomitant medication known to worsen dyspeptic symptoms (i.e. NSAIDs). * Patients with Type I or II Diabetes Mellitus * Patients with pathological finding in gastroscopy within 12 weeks prior to enrolment * Patients with positive breath test for H. pylori within 12 weeks prior to enrolment * Patients with chronic liver insufficiency * Pregnant or breastfeeding female patients.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if the Gastromotal 13C-octanoic acid breath test can identify the dyspeptic patients with delayed gastric emptying (GE) who profit more from prokinetic therapy (Domperidon) than dyspeptic patients with normal GE when assessed with the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Secondary Objective: * To optimize inclusion criteria to find the best population for the demonstration of the clinical relevance of the test in terms of cut-off point t1/2 in the diagnosis of GE and Gastrointestinal Symptom Rating Scale (GSRS) * To find the best time window of treatment with Domperidon, i.e. compare the treatment effect of the GSRS after 2 and 4 weeks of treatment * Correlation of improvement of dyspeptic symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire and normalization of gastric emptying in patients with delayed gastric emptying at baseline * Rate of patients with delayed gastric emptying (t1/2 > 110 min) at baseline (visit 1) who show normalisation of gastric emptying after 4 weeks treatment with Domperidon using the Gastromotal breath test * Assessment of safety in terms of adverse effects;Primary end point(s): Comparison of change of dyspeptic symptoms following prokinetic therapy with domperidon as assessed by GSRS questionnaire in patients with delayed GE vs. normal GE;Timepoint(s) of evaluation of this end point: Day 28	—

Measure

Time frame

Main Objective: To investigate if the Gastromotal 13C-octanoic acid breath test can identify the dyspeptic patients with delayed gastric emptying (GE) who profit more from prokinetic therapy (Domperidon) than dyspeptic patients with normal GE when assessed with the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Secondary Objective: * To optimize inclusion criteria to find the best population for the demonstration of the clinical relevance of the test in terms of cut-off point t1/2 in the diagnosis of GE and Gastrointestinal Symptom Rating Scale (GSRS) * To find the best time window of treatment with Domperidon, i.e. compare the treatment effect of the GSRS after 2 and 4 weeks of treatment * Correlation of improvement of dyspeptic symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire and normalization of gastric emptying in patients with delayed gastric emptying at baseline * Rate of patients with delayed gastric emptying (t1/2 > 110 min) at baseline (visit 1) who show normalisation of gastric emptying after 4 weeks treatment with Domperidon using the Gastromotal breath test * Assessment of safety in terms of adverse effects;Primary end point(s): Comparison of change of dyspeptic symptoms following prokinetic therapy with domperidon as assessed by GSRS questionnaire in patients with delayed GE vs. normal GE;Timepoint(s) of evaluation of this end point: Day 28

—

Secondary

Measure	Time frame
Secondary end point(s): Day 28;Timepoint(s) of evaluation of this end point: Day 28	—

Countries

Germany

Contacts

Public ContactINFAI GmbH

INFAI GmbH

sa@infai.de492218804441

Outcome results

None listed

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