NCT04281667 (MOBILE2) is a Phase 4 clinical trial of Oral Antibiotics in Rectal Adenocarcinoma, sponsored by Helsinki University Central Hospital.

Who is sponsoring NCT04281667?

NCT04281667 is sponsored by Helsinki University Central Hospital.

What drugs are being tested in NCT04281667?

Interventions in NCT04281667: Oral Antibiotics, Placebo, Mechanical Bowel Preparation.

What condition does NCT04281667 study?

NCT04281667 studies Rectal Adenocarcinoma, Rectum Neoplasm, Rectum Carcinoma, Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Surgical Site Infection, Surgery--Complications.

Is NCT04281667 still recruiting?

NCT04281667 is currently active, enrolled. Last updated 17 November 2022.

Last reviewed 2022-11-17 · How we verify

NCT04281667: MOBILE2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

Active, enrolled Phase 4 Last updated 17 November 2022

What this trial tests

Phase 4 trial testing Oral Antibiotics in Rectal Adenocarcinoma in 604 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 March 2020

Primary endpoint
9 November 2022

10 October 2027

Quick facts

Lead sponsor	Helsinki University Central Hospital
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	604
Start date	18 March 2020
Primary completion	9 November 2022
Estimated completion	10 October 2027
Sites	3 locations across Finland

Drugs / interventions tested

Oral Antibiotics
Placebo
Mechanical Bowel Preparation — full drug profile →

Conditions studied

Rectal Adenocarcinoma — all drugs for Rectal Adenocarcinoma →
Rectum Neoplasm — all drugs for Rectum Neoplasm →
Rectum Carcinoma — all drugs for Rectum Carcinoma →
Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Helsinki University Central Hospital

Who can join

18 and older, any sex, with Rectal Adenocarcinoma or Rectum Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Morbidity After Mechanical Bowel Preparation and Oral Antibiotics Prior to Rectal Resection: The MOBILE2 Randomized Clinical Trial.
Koskenvuo L, Lunkka P, Varpe P, Hyöty M, et al · · 2024 · cited 38× · PMID 38506889 · DOI 10.1001/jamasurg.2024.0184
Mechanical bowel preparation and antibiotics in elective colorectal surgery: network meta-analysis.
Tan J, Ryan ÉJ, Davey MG, McHugh FT, et al · · 2023 · cited 21× · PMID 37257059 · DOI 10.1093/bjsopen/zrad040
Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial-study protocol.
Koskenvuo L, Lunkka P, Varpe P, Hyöty M, et al · · 2021 · cited 8× · PMID 34244284 · DOI 10.1136/bmjopen-2021-051269

Verify or expand the search:

Other trials of Oral Antibiotics

Trials testing the same drug.

NCT06080698 — Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial · NA · recruiting

Other recruiting trials for Rectal Adenocarcinoma

Currently open trials in the same condition.

NCT07407465 — Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal · Phase 2 · recruiting
NCT07198165 — SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC · Phase 2 · recruiting
NCT06997497 — A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-108 · Phase 3 · recruiting
NCT06780787 — FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery · Phase 2 · recruiting
NCT06908031 — SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy for HIgh-Risk pMMR/MSS Rectal Cancer · Phase 2 · recruiting

Other Helsinki University Central Hospital trials

Trials by the same sponsor.

NCT07423637 — The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectivene · NA · not yet recruiting
NCT07462559 — KF2025#1 Trial: Ketamine, Cannabidiol and Cobicistat Interaction Study · Phase 1 · not yet recruiting
NCT07458984 — FMT Capsules for rCDI · Phase 3 · not yet recruiting
NCT07001423 — ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly · NA · recruiting
NCT07155629 — Neoadjuvant Treatment vs Upfront Surgery for Left-Sided Pancreatic Cancer · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04281667 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Helsinki University Central Hospital
Last refreshed: 17 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04281667.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing