Prospective, double-blind diagnostic study of confocal laser endomicroscopy (CLE) for wheat sensitivity (WS) in patients with irritable bowel syndrome

Prospective, double-blind diagnostic study of confocal laser endomicroscopy (CLE) for wheat sensitivity (WS) in patients with irritable bowel syndrome - LEWIS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010123

Enrollment

130

Registered

2016-03-22

Start date

2016-05-24

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K58.0 K58.9

Interventions

Group 1: Patients with the irritable bowel syndrome fulfilling the Rome III criteria will be examined by confocal laser endomicroscopy for mucosal reactions to duodenal instillation of suspensions of

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: fulfillment of Rome III criteria for IBS daily symptoms worsening after meals score = 175 of the IBS-SSS questionnaire normal gastroscopy including histology normal colonoscopy within the last five years able and willing to follow a GFD capable of understanding and signing an informed consent form

Exclusion criteria

Exclusion criteria: chronic gastrointestinal disease; elevated anti-TTG IgA (reference 38.5°C); CRP >0.5 mg/l; WBC =10.5/nl; chronic heart failure (NYHA III and IV); pregnancy; renal failure with increased creatinine; allergy to fluorescein or soy; clinically evident cognitive disabilities

Design outcomes

Primary

Measure	Time frame
Index test: IBS patients will be tested by CLE (confocal laser endomicroscopy) for wheat-induced changes. Reference test: IBS patients responding to gluten-free diet will be classified as having WS. Patients will be classified as responders if they report on weekly interviews complete or considerable relief of IBS symptoms on at least 50% of weeks over a 2-month period of gluten-free diet, and an abdominal pain score assessed by symptom diary improved by at least 30%.	—

Measure

Time frame

Index test: IBS patients will be tested by CLE (confocal laser endomicroscopy) for wheat-induced changes. Reference test: IBS patients responding to gluten-free diet will be classified as having WS. Patients will be classified as responders if they report on weekly interviews complete or considerable relief of IBS symptoms on at least 50% of weeks over a 2-month period of gluten-free diet, and an abdominal pain score assessed by symptom diary improved by at least 30%.

—

Secondary

Measure	Time frame
Change in IBS symptoms (IBS-SSS) and quality of life (IBS-QOL, EQ-5D), proportion of responders at follow-up after 6 and 12 months, proportions of early and sustained responders	—

Countries

Germany

Contacts

Public ContactCornelia Krohn

Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charite - Campus Benjamin Franklin

cornelia.krohn@charite.de030 450 51 44 15

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026