Comparative Study Between Colonoscopy Bowel Preparation With Clear Liquids, With and Without Two Servings of High Energy Nutritional Supplement

Summary

The high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions, yet it has been used off-label to alleviate the effects of hunger during bowel preparation for colonoscopy. Its impact in mucosa visualization quality and hunger alleviation is unknown. The product is liquid and nutritious but it is not transparent, thus it is conceivable that it could alleviate the discomfort of hunger during the preparation but possibly compromising mucosa visualization. In this study, participants who will undergo a colonoscopy (requested for an explicit medical indication) will take two bottles of the nutritional supplement during the usual bowel preparation. The quality of mucosal visualization and the participants opinion regarding satiety and product tolerance during bowel preparation will then be analysed.

Conditions

• Colonoscopy
• Bowel Preparation

Interventions

DIETARY_SUPPLEMENT

Resource® Energy Apricot

Bowel preparation as usual plus two bottles of Resource® Energy Apricot (one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), with ingestion of one bottle of 200 mL of the dietary supplement at 08:00 and the other at 12:00, and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 (Klean-Prep®) in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning). Colonoscopy.

OTHER

Bowel preparation as usual.

Bowel preparation as usual (one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 (Klean-Prep®) in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning). Colonoscopy.

Sponsors & Collaborators

• Nestlé Portugal SA

  collaborator UNKNOWN

• Angelini Pharma Portugal, Unipessoal, Lda

  collaborator UNKNOWN

• Clínica de Gastroenterologia

  lead OTHER

Principal Investigators

• José AS Medeiros, PhD · Clínica de Gastroenterologia

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-30

Primary Completion

2022-05-28

Completion

2022-05-28

Countries

• Portugal

Study Locations