COMPARATIVE STUDY BETWEEN TWO SUBSTRATES FOR THE BACTERIAL OVERGROWTH BREATH TEST

RANDOMIZED, MULTICENTRIC CLINICAL TRIAL, COMPARISON BETWEEN LACTITOL AND LACTULOSE AS SUBSTRATES BREATH TEST FOR THE DIAGNOSIS OF BACTERIAL OVERGROWTH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001368-86-ES

Enrollment

200

Registered

2022-12-14

Start date

2023-06-14

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Intestinal bacterial overgrowth MedDRA version: 20.0 Level: LLT Classification code 10071061 Term: Small intestinal bacterial overgrowth System Organ Class: 100000004862 MedDRA version: 21.0 Level: PT Classification code 10065439 Term: Hydrogen breath test System Organ Class: 10022891 - Investigations

Interventions

Trade Name: LACTULOSA Pharmaceutical Form: Oral solution INN or Proposed INN: LACTULOSE CAS Number: 4618-18-2 Concentration unit: g gram(s) Concentration type: equal Concentration number: 10- Trade N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients between 18 and 80 years old - Symptoms suggestive of intestinal bacterial overgrowth that require a diagnostic test for confirmation. - Signature of the informed consent for inclusion in this study by the patient. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - Patients with psychiatric or neurological disorders who are not able to comply with the recommendations prior to the tests and who cannot adequately follow the instructions during the collection of the samples. - History of total or partial gastrectomy, vagotomy or any type of intestinal resection (including bariatric endoscopy).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the concordance between lactulose and lactitol as substrates in the performance of the breath test in the diagnosis of bacterial overgrowth;Secondary Objective: • Evaluate the symptoms produced after the administration of each substrate during the breath test for the diagnosis of bacterial overgrowth. • Evaluate the late symptoms produced after the administration of each substrate during the 24 hours after performing the breath test. • Assess the acceptability of the breath test with each substrate by the patient.nto for the diagnosis of bacterial overgrowth.;Primary end point(s): Sintoms during each test wich difeferent substract Concordance between SIBO trials with each substrate;Timepoint(s) of evaluation of this end point: 12 month	—

Measure

Time frame

Main Objective: To evaluate the concordance between lactulose and lactitol as substrates in the performance of the breath test in the diagnosis of bacterial overgrowth;Secondary Objective: • Evaluate the symptoms produced after the administration of each substrate during the breath test for the diagnosis of bacterial overgrowth. • Evaluate the late symptoms produced after the administration of each substrate during the 24 hours after performing the breath test. • Assess the acceptability of the breath test with each substrate by the patient.nto for the diagnosis of bacterial overgrowth.;Primary end point(s): Sintoms during each test wich difeferent substract Concordance between SIBO trials with each substrate;Timepoint(s) of evaluation of this end point: 12 month

—

Secondary

Measure	Time frame
Secondary end point(s): Patient preference. Assess the gas lifting time with each substrate;Timepoint(s) of evaluation of this end point: 12 m	—

Countries

Spain

Contacts

Public ContactVeronica Martin Dominguez

Hospital Universitario de La Princesa

veronicamartin29@yahoo.es0034915202254

Outcome results

None listed

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