Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy

Last updated: July 18, 2024
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Low-residue full nutrition formula podwer

Self-prepared low-residue diet

Clinical Study ID

NCT06514989
FNFP2024
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the adequate bowel preparation rate was significantly improved in low-residue full nutrition formula podwer group. However, there are still a considerable number of patients in the process of taking 3L PEG appeared bloating, abdominal pain, nausea, vomiting and other adverse reactions, indicating some subjects can not tolerate the dosage of 3L PEG. In order to reduce adverse reactions and provide more options for people with low PEG tolerance, this study intends to compare the effects of low-residue FNFP combined with 2L PEG and self-provided low-residue diet combined with 3L PEG on the quality bowel preparation, colonoscopy lesions detection, adverse reactions, and tolerance, compliance and satisfaction of subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult subjects between the ages of 18 and 75 who were scheduled for screening,monitoring, and diagnostic colonoscopy.

Exclusion

Exclusion Criteria:

  • severe heart, brain, lung, kidney complications or a history of acute myocardialinfarction within six months.

  • a history of abdominal or pelvic surgery, BMI > 28 or BMI < 18.5, inflammatory boweldisease, constipation (less than 3 bowel movements in the past week, with strenuousbowel movements, hard stool, small volume), or intestinal obstruction.

  • imaging and laboratory tests are highly suspicious of colorectal cancer or warningsigns and symptoms of colorectal cancer: blood in the stool, black stool,unexplained anemia and significant weight loss, abdominal mass, and positive digitalrectal examination.

Study Design

Total Participants: 750
Treatment Group(s): 2
Primary Treatment: Low-residue full nutrition formula podwer
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Lu'an People's Hospital

    Lu'an, Anhui
    China

    Site Not Available

  • PLA 909 Hospital

    Quanzhou, Fujian
    China

    Site Not Available

  • PLA 909 Hospital

    Zhangzhou, Fujian
    China

    Site Not Available

  • Huizhou Central People's Hospital

    Huizhou, Guangdong
    China

    Site Not Available

  • Jiangmen Central Hospital

    Jiangmen, Guangdong
    China

    Site Not Available

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei
    China

    Site Not Available

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjin, Jiangsu
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Nanjing Gulou Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu
    China

    Site Not Available

  • Jiangsu Subei People's Hospital

    Yangzhou, Jiangsu
    China

    Site Not Available

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • the central hospital of Dalian

    Dalian, Liaoning
    China

    Site Not Available

  • Northern Theater General Hospital

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Shengli Oilfield Central Hospital

    Dongying, Shandong
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Changhai Hospital, Naval Medical University

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Ankang Central Hospital

    Ankang, Shanxi
    China

    Site Not Available

  • Yibin Second People's Hospital

    Yibin, Sichuan
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • East China Hospital, Fudan University

    Shanghai,
    China

    Site Not Available

  • Shanghai Seventh People's Hospital

    Shanghai,
    China

    Site Not Available

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