Buijs Maria Magdalena, Kobaek-Larsen Morten, Kaalby Lasse, Baatrup Gunnar
Department of Clinical Research, University of Southern Denmark, Winsløwsparken 19, 3rd floor, 5000, Odense, Denmark.
Department of Surgery, Odense University Hospital, Baagøes Allé 15, Forskningshus, 5700, Svendborg, Denmark.
BMC Gastroenterol. 2018 Jun 25;18(1):95. doi: 10.1186/s12876-018-0824-9.
A high rate of complete colon capsule endoscopy (CCE) investigations is required for a more widespread use of CCE. The objective of this study was to assess if coffee or chewing gum can increase excretion of the colon capsule within battery life time (excretion rate).
One hundred eighty six screening participants with a positive immunochemical fecal occult blood test were included in this single-centre randomized controlled trial with blinding of the investigators to the randomization. Participants received instant coffee, chewing gum or nothing in addition to the standard bowel preparation.
The intention was to include 57 participants in the coffee group, 61 in the chewing gum group and 60 in the control group, on 8 participants data were missing. A total of 165 participants were included in a per protocol analysis. Exclusion was due to not receiving the allocated intervention (8 coffee, 4 chewing gum) and technical failure of the capsule (1 coffee). The excretion rate was 58% in the coffee group (n = 48), 63% in the chewing gum group (n = 57) and 55% in the control group (n = 60, p > 0.2). Transit times were similar in all groups. The excretion rate was low in participants who had transit times over 10 h (14%). A strong correlation was found between adequate cleansing and excretion of the capsule. There were no serious adverse events related to the interventions or CCE investigations.
Chewing gum and coffee did not improve excretion rate in this study. An effect of chewing gum could not be proven, possibly due to sample size. Since chewing gum might improve excretion rates, is cheap and has no known side effects, it needs to be considered in future bowel preparation trials for CCE.
NCT02303756 , registered on December 1st 2014.
为了更广泛地应用全结肠胶囊内镜检查(CCE),需要较高的全结肠胶囊内镜检查完成率。本研究的目的是评估咖啡或口香糖是否能在电池续航时间内提高结肠胶囊的排泄率(排泄速率)。
186名免疫化学法粪便潜血试验呈阳性的筛查参与者被纳入这项单中心随机对照试验,研究人员对随机分组情况进行了盲法处理。除了标准的肠道准备外,参与者还分别接受速溶咖啡、口香糖或不接受任何额外干预。
原计划咖啡组纳入57名参与者,口香糖组纳入61名参与者,对照组纳入60名参与者,有8名参与者的数据缺失。共有165名参与者纳入符合方案分析。排除原因包括未接受分配的干预措施(8名咖啡组参与者、4名口香糖组参与者)以及胶囊技术故障(1名咖啡组参与者)。咖啡组的排泄率为58%(n = 48),口香糖组为63%(n = 57),对照组为55%(n = 60,p > 0.2)。所有组的转运时间相似。转运时间超过10小时的参与者排泄率较低(14%)。发现肠道清洁充分与胶囊排泄之间存在强相关性。没有与干预措施或全结肠胶囊内镜检查相关的严重不良事件。
在本研究中,口香糖和咖啡并未提高排泄率。口香糖的效果未能得到证实,可能是由于样本量的原因。由于口香糖可能提高排泄率、价格便宜且无已知副作用,因此在未来全结肠胶囊内镜检查的肠道准备试验中需要考虑使用。
NCT02303756,于2014年12月1日注册。