NCT07699809

Brief Summary

The goal of this study is to evaluate whether a "thirst kit" (lemon popsicle) is effective in reducing thirst intensity in patients undergoing hospital bowel preparation for colonoscopy. The study also aims to assess the impact of the thirst kit on associated symptoms and patient satisfaction. The main questions it aims to answer are:

  • Does the thirst kit reduce the intensity of thirst after bowel preparation for colonoscopy?
  • Does the thirst kit reduce symptoms such as dry mouth and dry throat?
  • How satisfied are patients when using the thirst kit compared to a placebo? Researchers will compare the thirst kit to a placebo to determine its effectiveness in managing thirst during the pre-colonoscopy period. Participants will:
  • Be randomly assigned to receive either the thirst kit (lemon popsicle) or a placebo
  • Use the assigned intervention during the hospital preparation period for colonoscopy
  • Rate thirst intensity, associated symptoms, and satisfaction using numerical scales

Trial Health

77
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress89%
Dec 2025Sep 2026

Study Start

First participant enrolled

December 8, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2026

Expected
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 13, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

April 7, 2026

Last Update Submit

July 7, 2026

Conditions

ThirstBowel Preparation for ColonoscopyColonoscopy

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of the study is the intensity of thirst, assessed using a numerical scale (0-10) after administration of the thirst kit or placebo.

    The intensity of thirst, measured using a numerical scale from 0 to 10, was assessed after administration of the thirst kit or placebo in patients undergoing hospital preparation for colonoscopy.

    10 minutes before the sedation for the exam starts (when the patient arrives in the examination room)

Study Arms (2)

Intervention

EXPERIMENTAL

Group lemon popsicle: Group that will receive the lemon popsicle

Other: lemon popsicle

Placebo

PLACEBO COMPARATOR

Group placebo: Group that will recive de placebo (water blister)

Other: Water blister pack

Interventions

lemon popsicleOTHER

The intervention group receives a "Thirst relife kit A" consisting of an encouraging message and a 60g lemon-flavored popsicle from the Jundiá® brand (Ingredients: water, sugar, glucose syrup, concentrated lemon juice, citric acid, thickeners, artificial flavoring).

Also known as: Thirst kit relife
Intervention
Water blister packOTHER

The control group receives a "Thirst Relife Kit B" consisting of the same encouraging message, a cotton ball, and a 10 ml blister pack of distilled water.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • both sexes
  • aged 18 years or older, with clear awareness and good cooperation
  • who underwent colonoscopy with hospital bowel preparation

You may not qualify if:

  • any risk of oral fluid aspiration
  • swallowing disorders
  • post-operative advanced head and neck surgeries
  • advanced head and neck neoplasia, active oral diseases (oral mucosal lesions, stomatitis, among others)
  • history of gastric surgeries (gastrectomized, upper gastrointestinal tract surgeries for obesity)
  • use of GLP-1 analog medications and derivatives in the last 10 days according to hospital protocol (e.g., semaglutide, liraglutide, dulaglutide, tirzepatide...)
  • history of dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sírio Libanês

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (1)

  • 1. International Agency for Research on Cancer. GLOBOCAN 2020: estimated cancer incidence, mortality and prevalence worldwide in 2020. Lyon: IARC; 2021. 2. Islami F, Ward EM, Sung H, Cronin KA, Tangka FKL, Sherman RL, et al. Annual report to the nation on the status of cancer, part I: National cancer statistics. J Natl Cancer Inst. 2021. 3. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-49. 4. Winawer SJ, Zauber AG, O'Brien MJ, Ho MN, Gottlieb L, Sternberg SS, et al. Randomized comparison of surveillance intervals after colonoscopic removal of newly diagnosed adenomatous polyps: the National Polyp Study Workgroup. N Engl J Med. 1993;328(13):901-6. 5. Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, et al. Prevention of colorectal cancer by colonoscopic polypectomy: the National Polyp Study Workgroup. N Engl J Med. 1993;329(27):1977-81. 6. Knudsen AB, Rutter CM, Peterse EFP, Lietz AP, Seguin CL, Meester RGS, et al. Colorectal cancer screening: an updated modeling study for the US Preventive Services Task Force. JAMA. 2021;325(19):1998-2011. doi:10.1001/jama.2021.5746. 7. Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005;61(3):378-84. 8. Parente F, Marino B, Crosta C. Bowel preparation before colonoscopy in the era of mass screening for colorectal cancer: a practical approach. Dig Liver Dis. 2009;41(2):87-95. doi:10.1016/j.dld.2008.06.005. 9. Green SM, Leroy PL, Roback MG, Irwin MG, Andolfatto G, Babl FE, et al. An international multidisciplinary consensus statement on fasting before procedural sedation in adults and children. Anaesthesia. 2020;75(3):374-85. doi:10

    BACKGROUND

Central Study Contacts

Carlos Frederico Sparapan Marques

CONTACT

+5511996250751carlos.frederico@hc.fm.usp.br

Júlia Bernardes Ferreira Gomes

CONTACT

+5531984637761julia.gomes@hsl.org.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

July 13, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

August 12, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)