NCT04027504

Brief Summary

Patients who are due to have planned bowel surgery will be invited to take part in the study. Those that consent, will be given a 5 day supply of 'Fitabisc' (a biscuit designed to have the potential to provide nutritional support).Participants will be asked to eat 4 biscuits a day for a minimum of 5 days prior to their surgery before they are admitted to hospital. They will be asked to complete questionnaires to record the palatability of the biscuit, how much of the daily amount they were able to eat and if they could not eat the full amount, the reason for this. Information will also be collected on patient's demographic and clinical details. We will follow participants' progress after surgery so we can be alerted to any possible medium to longer term adverse effects of eating the biscuit, though none are expected.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

June 26, 2019

Last Update Submit

July 19, 2019

Conditions

Preoperative CareAntioxidants

Outcome Measures

Primary Outcomes (1)

  • Palatibility Test

    Do patients about to undergo colorectal surgery find Fitabisc sufficiently palatable that they can eat the biscuit in the required quantities for 10 days prior to their surgery?

    10 days prior to surgery

Study Arms (1)

Fitabisc

EXPERIMENTAL

Participants receiving fitabisc preoperatively

Dietary Supplement: Fitabisc

Interventions

FitabiscDIETARY_SUPPLEMENT

Biscuits containing antioxidants

Fitabisc

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 16 and 90 years
  • Having planned abdominal surgery at Castle Hill Hospital

You may not qualify if:

  • People who do not give informed consent
  • People with a known or suspected allergy to gluten and / or dairy products
  • People already taking any of the following as dietary supplements: vitamins C, E, selenium or glutamine
  • People with haemochromatosis, thalassaemia, kidney disease, liver disease or Reye syndrome
  • People with type 1 diabetes or people with type 2 diabetes who take insulin or hypoglycaemic drugs such as Metformin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castle Hill Hospital

Hull, East Yorkshire, Hu16 5hl, United Kingdom

Location

Study Officials

  • John Hartley, MD FRCS

    Hull and East Yorkshire NHS Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 22, 2019

Study Start

January 1, 2018

Primary Completion

September 20, 2018

Study Completion

December 20, 2018

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)